chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Intense pain in left arm at and near injection site. Unable to move arm in usual directions. Pain comes and goes (was better for a few days) but more than one week after injection, the pain today at the end of the day is intense and required pain medications. Have been unable to reach right armpit at all while showering,
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Large inflamed reddened area on deltoid measuring approx 2in in diameter. Area painful, itchy and hot to touch
Age: 93.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Contusion, Haemorrhage
Clinical narrative: Patient received her vaccines on 12/4/24. She called on 12/5/24 to tell us she was "bleeding" down to her elbow (right arm). She was describing a bruise. She is taking warfarin. She seemed concerned so she was told to contact her primary care provider. She called us back on Monday, Dec. 9th, and told us she went to the ER on Friday, Dec. 6th, because she was concerned. The ER wouldn't release any information to us. We called NP - her primary care provider. She couldn't release any information, but said she's fine.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye swelling, Fatigue, Lacrimation increased, Malaise
Clinical narrative: Needed follow up medical care and eye doctor visit after developing TEN. Still not resolved.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Rash, Skin exfoliation
Clinical narrative: Needed follow up medical care and eye doctor visit after developing TEN. Still not resolved.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Toxic epidermal necrolysis
Clinical narrative: Needed follow up medical care and eye doctor visit after developing TEN. Still not resolved.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient who was inadvertently administered PROQUAD instead of MMR-II and VARIVAX; No symptoms reported; This spontaneous report has been received from a nurse regarding a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On an unknown date, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter, administered for prophylaxis (lot number reported as Y006771, which has been verified as valid, expiration date not reported but validated as 24-SEP-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and varicella virus vaccine live (oka/merck) (VARIVAX) injection for prophylaxis (strengths, doses, vaccination schemes, routes of administration, anatomical sites of injection, lot number, and expiration dates were not provided) (Wrong product administered).  No symptoms were reported in the patient.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AEs or PQC reported; Caller reported MMR II was reconstituted with Non-Merck Diluent and was administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history and concomitant medications were not provided.  On 08-DEC-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, 0.5 milliliter, lot #X026219, expiration date: 06-NOV-2025, administered for prophylaxis (strength, route of administration and anatomical location were not provided) which was reconstituted with diluent for Heplasav B lot # 943008 with expiration date 30-SEP-2025 (Wrong solution used in drug reconstitution).  No additional adverse events.
Sex: F
Vaccine: RVX
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Patient had experiencing dizziness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, immediately after receiving RSV vaccine, the patient experienced dizziness (Verbatim: Patient had experiencing dizziness). The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to RSV vaccine.     It was unknown if the company considered the dizziness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 13-NOV-2024 This case was reported by a patient via interactive digital media. The patient bad reaction to RSV vaccine last year. The patient experienced dizziness right after RSV shot it happened and did not went away.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Oedema
Clinical narrative: pain at the infection site; erythema at injection site; Calor / warmth / heat at injection site; Edema; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery (Redo Nissen fundoplication surgery with Hernia x2 repair and post operation 6 weeks). Concurrent medical conditions included hiv infection.   On 14-NOV-2024 09:30, the patient received the 1st dose of Shingrix (injection, left deltoid) .5 ml. On 14-NOV-2024, 10 min after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the infection site), injection site erythema (Verbatim: erythema at injection site), injection site warmth (Verbatim: Calor / warmth / heat at injection site), injection site edema (Verbatim: Edema) and headache (Verbatim: Headache). The outcome of the injection site pain, injection site erythema, injection site warmth, injection site edema and headache were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site edema and headache to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, injection site warmth, injection site edema and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-NOV-2024 The reporter was the patient who received his Shingrix in his left deltoid. Ten minutes after receiving the vaccine he had pain at the infection site, redness at the injection site and a headache. Twelve hours after the injection he had edema and hot to touch skin at the injection site. All symptoms were not resolved. Patient did not go to the emergency department.  However, he did go to the Urgent Care for evaluation. Patient did not have the lot number of vaccine. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she's still in pain from the injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (she's still in pain from the injection) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2024, the patient experienced VACCINATION SITE PAIN (she's still in pain from the injection). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency and Naproxen sodium (Aleve) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (she's still in pain from the injection) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       No concomitant medications were provided. The patient received a vaccination on 11-SEP-2024 and continued to experience pain at the injection site. Despite attempting various remedies, including muscle relaxants, physical therapy, heat application, Tylenol, and Aleve, she had found no relief. It was indicated that the injection may have been administered too high in her arm. After three months, there had been no improvement in her condition. She was uncertain whether the pain was a result of the medication or the injection itself, which was administered by a technician at pharmacy. She seeks guidance on how to alleviate the pain.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numb spot on the back of my left hand between my thumb and wrist. The same thing happened on the top of my left foot last year 24 hours after I got my Covid vaccine in 2023. I was told it couldn?t be related to the vaccine so got it again this year but now I have a numb spot on my hand.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Morning sickness
Clinical narrative: Patient states she is 25 weeks pregnant. Received the vaccine during a flu Rodeo. Within 15 minutes, she started throwing up.  Stated she received influenza vaccine in the past without any allergic reaction.  Perhaps reaction was due to pregnancy.  Patient was discharged home within 2-3 hours without medication since both her and baby were doing well.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: Extreme dizzyness / Vertigo lasting for at least one week (ongoing)
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated, Diplopia, Dysphagia, Eyelid ptosis
Clinical narrative: Myasthenia Gravis Exacerbation with shingrix vaccine/exacerbation of myasthenia gravis 5 days after the vaccination; This serious case was reported in a literature article and described the occurrence of myasthenia gravis aggravated in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference  Concurrent medical conditions included myasthenia gravis (for the last eight years). Concomitant products included prednisone and pyridostigmine.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced myasthenia gravis aggravated (Verbatim: Myasthenia Gravis Exacerbation with shingrix vaccine/exacerbation of myasthenia gravis 5 days after the vaccination) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulin G human. The outcome of the myasthenia gravis aggravated was resolving.   The reporter considered the myasthenia gravis aggravated to be related to Shingrix.     The company considered the myasthenia gravis aggravated to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 09-Dec-2024,  This patient diagnosed with stable seropositive generalized myasthenia gravis (MG) for the last eight years. He was on prednisone 10 mg every other day and Pyridostigmine 60 mg twice daily. He presented to the Neurology clinic with worsening ocular symptoms including horizontal diplopia worse with right lateral gaze, generalized weakness, and fatigue. He also complained about difficulty swallowing and orthopnea. 5 days before the presentation, he received the Shingrix vaccine. There was no change in medications or infections in the interim. On examination, he had fatigable ptosis with Cogan's Sign, fatigable arm weakness, and single breath count test of 38. He was admitted and treated with IVIg (1g/kg body weight) for five days, which improved dysphagia and orthopnea but did not improve the diplopia. His dose of prednisone was increased to 30 mg every other day and Pyridostigmine 60 mg, three times a day, which improved his ocular symptoms 2 months later. The stable myasthenia gravis that got exacerbated after a single dose of Shingrix vaccination. The patient had been stable for the past eight years and developed an exacerbation of MG 5 days after the vaccination. The author described a case that described the possible association between vaccination and myasthenia exacerbation.; Sender's Comments: Myasthenia gravis aggravated is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Immunoglobulin therapy, Muscle fatigue, Myasthenia gravis, Neurological symptom
Clinical narrative: Myasthenia Gravis Exacerbation with shingrix vaccine/exacerbation of myasthenia gravis 5 days after the vaccination; This serious case was reported in a literature article and described the occurrence of myasthenia gravis aggravated in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference  Concurrent medical conditions included myasthenia gravis (for the last eight years). Concomitant products included prednisone and pyridostigmine.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced myasthenia gravis aggravated (Verbatim: Myasthenia Gravis Exacerbation with shingrix vaccine/exacerbation of myasthenia gravis 5 days after the vaccination) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulin G human. The outcome of the myasthenia gravis aggravated was resolving.   The reporter considered the myasthenia gravis aggravated to be related to Shingrix.     The company considered the myasthenia gravis aggravated to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 09-Dec-2024,  This patient diagnosed with stable seropositive generalized myasthenia gravis (MG) for the last eight years. He was on prednisone 10 mg every other day and Pyridostigmine 60 mg twice daily. He presented to the Neurology clinic with worsening ocular symptoms including horizontal diplopia worse with right lateral gaze, generalized weakness, and fatigue. He also complained about difficulty swallowing and orthopnea. 5 days before the presentation, he received the Shingrix vaccine. There was no change in medications or infections in the interim. On examination, he had fatigable ptosis with Cogan's Sign, fatigable arm weakness, and single breath count test of 38. He was admitted and treated with IVIg (1g/kg body weight) for five days, which improved dysphagia and orthopnea but did not improve the diplopia. His dose of prednisone was increased to 30 mg every other day and Pyridostigmine 60 mg, three times a day, which improved his ocular symptoms 2 months later. The stable myasthenia gravis that got exacerbated after a single dose of Shingrix vaccination. The patient had been stable for the past eight years and developed an exacerbation of MG 5 days after the vaccination. The author described a case that described the possible association between vaccination and myasthenia exacerbation.; Sender's Comments: Myasthenia gravis aggravated is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Orthopnoea
Clinical narrative: Myasthenia Gravis Exacerbation with shingrix vaccine/exacerbation of myasthenia gravis 5 days after the vaccination; This serious case was reported in a literature article and described the occurrence of myasthenia gravis aggravated in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference  Concurrent medical conditions included myasthenia gravis (for the last eight years). Concomitant products included prednisone and pyridostigmine.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced myasthenia gravis aggravated (Verbatim: Myasthenia Gravis Exacerbation with shingrix vaccine/exacerbation of myasthenia gravis 5 days after the vaccination) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulin G human. The outcome of the myasthenia gravis aggravated was resolving.   The reporter considered the myasthenia gravis aggravated to be related to Shingrix.     The company considered the myasthenia gravis aggravated to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 09-Dec-2024,  This patient diagnosed with stable seropositive generalized myasthenia gravis (MG) for the last eight years. He was on prednisone 10 mg every other day and Pyridostigmine 60 mg twice daily. He presented to the Neurology clinic with worsening ocular symptoms including horizontal diplopia worse with right lateral gaze, generalized weakness, and fatigue. He also complained about difficulty swallowing and orthopnea. 5 days before the presentation, he received the Shingrix vaccine. There was no change in medications or infections in the interim. On examination, he had fatigable ptosis with Cogan's Sign, fatigable arm weakness, and single breath count test of 38. He was admitted and treated with IVIg (1g/kg body weight) for five days, which improved dysphagia and orthopnea but did not improve the diplopia. His dose of prednisone was increased to 30 mg every other day and Pyridostigmine 60 mg, three times a day, which improved his ocular symptoms 2 months later. The stable myasthenia gravis that got exacerbated after a single dose of Shingrix vaccination. The patient had been stable for the past eight years and developed an exacerbation of MG 5 days after the vaccination. The author described a case that described the possible association between vaccination and myasthenia exacerbation.; Sender's Comments: Myasthenia gravis aggravated is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: administration after a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number P27511, expiry date 28-FEB-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: administration after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 18-NOV-2024 The reporter reported that the Menveo vaccine had been administered after an excursion which took place about 6 to 7 weeks ago, which led to incorrect storage of vaccine. The reporter mentioned that she did not think it was an adverse event. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinus headache
Clinical narrative: heavy congestion like getting a cold; Head congestion, like heavy sinus problems; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (heavy congestion like getting a cold) and SINUS HEADACHE (Head congestion, like heavy sinus problems) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 06-Dec-2024, the patient experienced NASOPHARYNGITIS (heavy congestion like getting a cold) and SINUS HEADACHE (Head congestion, like heavy sinus problems). At the time of the report, NASOPHARYNGITIS (heavy congestion like getting a cold) and SINUS HEADACHE (Head congestion, like heavy sinus problems) outcome was unknown.            No concomitant medication was reported.  It was reported that within 24 hours patient started getting the head congestion and it was worse for patient. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-779098 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779098:Wife's case
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: caused her to become more paralyzed by the multilateral sclerosis/caused her to become more paralyzed by the MS/spinal lesion; This spontaneous case was reported by an other health care professional and describes the occurrence of MULTIPLE SCLEROSIS (caused her to become more paralyzed by the multilateral sclerosis/caused her to become more paralyzed by the MS/spinal lesion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Miscarriage. Concurrent medical conditions included Restless leg syndrome.   On 12-Feb-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 12-Mar-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 12-Feb-2020, the patient experienced MULTIPLE SCLEROSIS (caused her to become more paralyzed by the multilateral sclerosis/caused her to become more paralyzed by the MS/spinal lesion) (seriousness criteria disability and medically significant). At the time of the report, MULTIPLE SCLEROSIS (caused her to become more paralyzed by the multilateral sclerosis/caused her to become more paralyzed by the MS/spinal lesion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had an AE with the vaccine when she had the treatment the 12-Feb-2020 and 12-Mar-2020. The vaccine attacked her spinal lesion and caused her to become more paralyzed by the multilateral sclerosis.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2024: Live follow-up received contains non-significant information (reference ID was added). On 05-Dec-2024: Significant follow up received and updated suspect product, added medical history of restless leg syndrome, removed vaccination onset date, reference number added.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Breakthrough COVID-19
Clinical narrative: This report involves a female in her early to mid 50's at the time of inoculations. DOSE#1 date 03/02/21 LOT#EN6205 DOSE#2 date 03/23/21 LOT#ER8727. This report is about a breakthrough case of COVID-19 from 2021. As a result the EUA medical countermeasure recipient lost her sense of smell and taste around August 16, 2021. To my knowledge three months later she had not recovered her sense of smell or taste. Her social media posts indicate she was inoculated a third time in January 2022. I am not aware of any further information about the adverse event. I recall her birthday. I am unsure of the year. I do know she was at least 50 years old at the time of inoculation.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: Rash & itchy -> left arm and posterior neck -> gave Benadryl
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Rash erythematous
Clinical narrative: red rash 2/3 upper arm itchiness - after 1 week still rash persists -
Age: 43.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Depression, Influenza like illness, Injection site pain, Injection site reaction, Lethargy
Clinical narrative: Significant pain in and around egg-sized welt on left upper arm at injection site. Not able to use arm for pushing/pulling. Lethargy, depression-like, and mild flu-like symptoms since Sunday morning, 12/8/24
Age: 43.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Musculoskeletal disorder, Urticaria
Clinical narrative: Significant pain in and around egg-sized welt on left upper arm at injection site. Not able to use arm for pushing/pulling. Lethargy, depression-like, and mild flu-like symptoms since Sunday morning, 12/8/24
Age: 65.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cough, Fatigue, Injection site pain, Odynophagia, Secretion discharge
Clinical narrative: Other than expected (muscle soreness in injection area, fatigue) I developed a sore throat (discomfort swallowing) that has migrated to a dry cough and need to clear mucus in throat.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood lactate dehydrogenase, Blood magnesium, Discomfort, Fatigue
Clinical narrative: Around 3 hours after shot, major muscles in legs started twitching (no pain at this time).  Around 9 hour after vaccination severe muscle pain  and acute heaviness in large muscles.  Around 12 hours after vaccine, migraine and nausea.  18 hours after vaccine, acute sweats. Severe nausea.  Large muscle pain continues (through day 11).  Severe exhaustion (bedbound for fit, active 62 yo) for 2.5 days.  Large muscle pain continue through day 11 now includes arm and back muscles.  Involuntary movement of left foot while left leg muscle experiences spasm.  Still exhausted, but not bedbound.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Hyperhidrosis, Metabolic function test, Migraine, Mobility decreased
Clinical narrative: Around 3 hours after shot, major muscles in legs started twitching (no pain at this time).  Around 9 hour after vaccination severe muscle pain  and acute heaviness in large muscles.  Around 12 hours after vaccine, migraine and nausea.  18 hours after vaccine, acute sweats. Severe nausea.  Large muscle pain continues (through day 11).  Severe exhaustion (bedbound for fit, active 62 yo) for 2.5 days.  Large muscle pain continue through day 11 now includes arm and back muscles.  Involuntary movement of left foot while left leg muscle experiences spasm.  Still exhausted, but not bedbound.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Myalgia, Nausea, Red blood cell sedimentation rate
Clinical narrative: Around 3 hours after shot, major muscles in legs started twitching (no pain at this time).  Around 9 hour after vaccination severe muscle pain  and acute heaviness in large muscles.  Around 12 hours after vaccine, migraine and nausea.  18 hours after vaccine, acute sweats. Severe nausea.  Large muscle pain continues (through day 11).  Severe exhaustion (bedbound for fit, active 62 yo) for 2.5 days.  Large muscle pain continue through day 11 now includes arm and back muscles.  Involuntary movement of left foot while left leg muscle experiences spasm.  Still exhausted, but not bedbound.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, Vitamin B12
Clinical narrative: Around 3 hours after shot, major muscles in legs started twitching (no pain at this time).  Around 9 hour after vaccination severe muscle pain  and acute heaviness in large muscles.  Around 12 hours after vaccine, migraine and nausea.  18 hours after vaccine, acute sweats. Severe nausea.  Large muscle pain continues (through day 11).  Severe exhaustion (bedbound for fit, active 62 yo) for 2.5 days.  Large muscle pain continue through day 11 now includes arm and back muscles.  Involuntary movement of left foot while left leg muscle experiences spasm.  Still exhausted, but not bedbound.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The covid shot was diluted, and it should not have been. Patient received a very small amount of the vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blood test, Chest X-ray, Decreased activity, Decreased appetite, Electroencephalogram
Clinical narrative: Evening of 9/22/24 around 4PM - patient was acting like he didn't feel well. Laying around, not active as usual, no appetite, whiney and cranky, he looked weak around his eyes. He was like this all day. He vomited. No fever, no medicine given. The next morning when he woke up 9/23/24 he was the same. He didn't want to eat or play. Still no fever. He just laid around and watching TV. He vomited around 10AM. Around noon, as he was laying down watching tv he started seizing. He had never had a seizure before. His body went stiff, his arms to his side, bent at the elbows. He wasn't convulsing violently, more like vibrating. I couldn't get his attention at all, he couldn't move or acknowledge me or anything around him. 911 was called. Paramedics transported us to the local Emergency room. While there, he had 3 more seizures before they transferred him. We were at (redacted) until release on 9/30/34. He had multiple tests and medications at each facility.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Irritability, Lumbar puncture, Magnetic resonance imaging, Malaise, Musculoskeletal stiffness
Clinical narrative: Evening of 9/22/24 around 4PM - patient was acting like he didn't feel well. Laying around, not active as usual, no appetite, whiney and cranky, he looked weak around his eyes. He was like this all day. He vomited. No fever, no medicine given. The next morning when he woke up 9/23/24 he was the same. He didn't want to eat or play. Still no fever. He just laid around and watching TV. He vomited around 10AM. Around noon, as he was laying down watching tv he started seizing. He had never had a seizure before. His body went stiff, his arms to his side, bent at the elbows. He wasn't convulsing violently, more like vibrating. I couldn't get his attention at all, he couldn't move or acknowledge me or anything around him. 911 was called. Paramedics transported us to the local Emergency room. While there, he had 3 more seizures before they transferred him. We were at (redacted) until release on 9/30/34. He had multiple tests and medications at each facility.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Ophthalmoplegia, Seizure, Unresponsive to stimuli, Urine analysis, Vomiting
Clinical narrative: Evening of 9/22/24 around 4PM - patient was acting like he didn't feel well. Laying around, not active as usual, no appetite, whiney and cranky, he looked weak around his eyes. He was like this all day. He vomited. No fever, no medicine given. The next morning when he woke up 9/23/24 he was the same. He didn't want to eat or play. Still no fever. He just laid around and watching TV. He vomited around 10AM. Around noon, as he was laying down watching tv he started seizing. He had never had a seizure before. His body went stiff, his arms to his side, bent at the elbows. He wasn't convulsing violently, more like vibrating. I couldn't get his attention at all, he couldn't move or acknowledge me or anything around him. 911 was called. Paramedics transported us to the local Emergency room. While there, he had 3 more seizures before they transferred him. We were at (redacted) until release on 9/30/34. He had multiple tests and medications at each facility.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Mobility decreased, Pain in extremity, X-ray limb
Clinical narrative: Patient reported severe pain in right arm; cannot move or speak due to pain. She reports the pain started a couple hours after she received the vaccine.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Given twice - did not show in state shots - no adverse events or added treatments
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mother observed a large area of redness that was slightly tender to touch on the left thigh, first noticed the day after the immunization was administered. She gave the child benadryl to help with any potential allergy, and marked the edges of the reaction with a marker on the child's leg. Patient was brought back to doctor's office on 11/27/24 to be checked, at which point the reaction was starting to decrease based on the markings that the mother made on the child's leg. Supportive care and Benadryl as needed were recommended, and advised to follow up if the area did not continue to resolve over the next 2-3 days.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was seen or a well child visit in the office.  The nurse administered a Tdap vaccine and did not realize until she was documenting the vaccine information in the chart that the vaccine was expired.  Dr. notified the parent of the mistake.  The patient was brought back to the office to administer the vaccine again.  The patient was alert and oriented and there was no noted adverse effect on the patient after receiving the expired vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: I have throbbing in my arm at the place of injection. The area of pain is about a 6 inch radius.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site bruising, Injection site haemorrhage, Musculoskeletal stiffness
Clinical narrative: First, 2 blood soaked cotton balls after injection; bruise fro 1 1/2 wks; the 2nd day my shoulder was stiff, sore and achey. It did not improve so I finally made an appointment to see Dr at community clinic. I started PT w/steroid treatment. Still working on its improvement.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Myalgia, Sleep disorder, X-ray
Clinical narrative: shoulder muscle pain that started early during the next day after the shot, difficulty in lifting and moving left arm, difficulty in lifting light weight with left arm, inability to sleep on left side without pain, right arm must do all the work, left arm almost useless but not entirely useless, use of NSAIDs is limited due to raise in blood pressure that occurs if use is increased. It is still a serious problem at the current time although I hope that it can someday be improved. Physical therapy since 10/30.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood magnesium normal, Blood phosphorus normal, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram abnormal
Clinical narrative: 8 witnessed seizure-like episodes while at home within 24 hours of vaccine administration without fevers/lab abnormalities, required hospital admission x2 days for continuous video EEG confirming no seizure episodes but encephalopathy
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Encephalopathy, Full blood count normal, Intussusception, Metabolic function test normal, Seizure like phenomena
Clinical narrative: 8 witnessed seizure-like episodes while at home within 24 hours of vaccine administration without fevers/lab abnormalities, required hospital admission x2 days for continuous video EEG confirming no seizure episodes but encephalopathy
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: 8 witnessed seizure-like episodes while at home within 24 hours of vaccine administration without fevers/lab abnormalities, required hospital admission x2 days for continuous video EEG confirming no seizure episodes but encephalopathy
Age: 84.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Diarrhoea, Flatulence
Clinical narrative: Gas and diarrhea. Diarrhea stopped 12/12/24
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECIEVED TWO FLU SHOTS IN THE SAME SEASON, FIRST DOSE 8/27/24 AND SECOND DOSE 12/12/24 - SPOKE WITH AND COUNSELED PATIENT.  SHE IS NOT CURRENTLY EXPERIENCING ANY SIDE EFFECTS
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine dose given was expired 3 days past its "Beyond Use Date" of 12/3/2024.  No adverse reactions reported.  Mom was informed and instructed to bring child back as soon as possible for a repeat dose per guidance from the Health Department and the CDC.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen, warm to the touch, redness, painful
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Fatigue
Clinical narrative: The patient received the RSV vaccine on 12/11/23 and received it again on 12/12/24. I spoke with her and she said she felt tired but had no other symptom.
Age: 55.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Inflammation, Inflammatory marker test, Pain
Clinical narrative: pt had full body pain and inflmamation  for months after the shots
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: Extreme indigestion and heartburn starting within 2 hours of vaccine received. I?ve had many Covid vaccines in the past but never indigestion  this bad.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea
Clinical narrative: patient developed diarrhea morning of 12/13 ( 3 days after receiving vaccination). No new medications, foods, or infections during week of vaccination.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: pt states her arm at injection site is very sore and bruised.    it is very swollen at site like a goose egg.  she has been taking Tylenol for pain.  it seems to be getting better very slowly but concerned because this never happened with any previous flu shot.  she might go see dr if doesn't get better.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Extra dose administered, Sluggishness
Clinical narrative: Patient received duplicate RSV vaccine. Received first RSV vaccine on 11/04/2023. Patient states she feels fine only reports feeling sluggish and has a little diarrhea but does not know if that is related to the vaccine.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Within 10 minutes of receiving vaccine, noticed redness to the area with itching.  By this morning, the redness had increased and the area is indurated with continued itching.  Oatmeal spray provides some relief.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Decreased appetite
Clinical narrative: Extreem loss of smell.. After third shot, loss of smell and appitite
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED DUPLICATE (REDUDANT) AREXVY (RSV SHOT) 8/3/24 AND HAD PREVIOUSLY RECEIVED ON 6/6/24 -- SPOKE WITH PATIENT 12/13/24 WHEN IT WAS DISCOVERED DOING AN AUDIT, SAID SHE HAD NOT EXPERIENCED ANY ILL EFFECT AND HAS SINCE THAT DATE RECEIVED OTHER VACCINES ALSO WITH NO ILL OUTCOMES
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Chest X-ray, Echocardiogram, Hypotonia, Lethargy, Pallor
Clinical narrative: Following the administration of patient's vaccines he had a brief episode where he stopped breathing, went pale, and limp. Parents were able to stimulate him to breathe again within 15 seconds. This ode was witnessed by his mothers and 2 medical assistants. Provider was notified and presented to exam room to reevaluate infant. Patient was pale and lethargic following episode. Patient has not had this happen before. Exam reassuring following episode. Heart rate and oxygen saturation were stable following episode. Decision made to transport infant to emergency room for further evaluation. Parents agreeable to this and would prefer transport via ambulance. Paramedics arrived quickly and transport was initiated with continuous pulse oximetry and heart rate monitoring.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Respiratory arrest
Clinical narrative: Following the administration of patient's vaccines he had a brief episode where he stopped breathing, went pale, and limp. Parents were able to stimulate him to breathe again within 15 seconds. This ode was witnessed by his mothers and 2 medical assistants. Provider was notified and presented to exam room to reevaluate infant. Patient was pale and lethargic following episode. Patient has not had this happen before. Exam reassuring following episode. Heart rate and oxygen saturation were stable following episode. Decision made to transport infant to emergency room for further evaluation. Parents agreeable to this and would prefer transport via ambulance. Paramedics arrived quickly and transport was initiated with continuous pulse oximetry and heart rate monitoring.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT RECEIVED SECOND DOSE OF SHINGRIX (SHINGLES VACCINE) LESS THAN 4 WEEKS APART FROM THE FIRST
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Inflammation, Injection site discomfort, Joint injury, Mobility decreased
Clinical narrative: My arm was prepped for the vaccine.  She inserted the needle and compressed the plunger, and the medication did not discharge into my arm.  She called over the Pharmacist and they examined the prefilled syringe and needle and could not see why it malfunctioned.  The Pharmacist apologized, got another vaccine.  The Tech prepped my arm again and specifically chose a secondary location.  When she compressed the plunger, I could feel the vaccine going in my arm and it felt like it was blowing up or expanding.  I have had cortisone shots in the sterno-clavicular joint for an injury and it felt similar.  Extremely painful, a filling sensation in my shoulder joint.  I am used to a day or two of soreness and a warm sensation from the vaccination, but this was much more painful.  A few days after the vaccination I had severe pain and limited range of motion.  Since then, I have continued to have pain to the point that I cannot sleep on that side.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered at inappropriate site, Rash, Sleep disorder, Syringe issue
Clinical narrative: My arm was prepped for the vaccine.  She inserted the needle and compressed the plunger, and the medication did not discharge into my arm.  She called over the Pharmacist and they examined the prefilled syringe and needle and could not see why it malfunctioned.  The Pharmacist apologized, got another vaccine.  The Tech prepped my arm again and specifically chose a secondary location.  When she compressed the plunger, I could feel the vaccine going in my arm and it felt like it was blowing up or expanding.  I have had cortisone shots in the sterno-clavicular joint for an injury and it felt similar.  Extremely painful, a filling sensation in my shoulder joint.  I am used to a day or two of soreness and a warm sensation from the vaccination, but this was much more painful.  A few days after the vaccination I had severe pain and limited range of motion.  Since then, I have continued to have pain to the point that I cannot sleep on that side.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cough, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: Sore throat and coughing at night
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 29.0
Sex: M
Vaccine: JEV1
Symptoms: Injection site pain, Pain
Clinical narrative: Patient experienced initial localized pain at injection site for the first few days, as expected for most intramuscular vaccines. Patient continued to experience myalgia since receiving vaccine one month ago. Pain is mild during range of motion movements, but moderate when conducting weighted pulling/pushing motions in the gym and daily activities.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibromyalgia, Headache, Inflammatory marker increased, Insomnia
Clinical narrative: First week pain and fever.  Then pain in my legs.  Over the months I progressively got sicker.  Stage three neuropathy,  fibromyalgia, extreme fatigue,  doctors did blood work and although inflammation markers were high they couldn?t find anything conclusive.  I couldn?t sleep, walk without pain and had constant headaches.  I?m still sick
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Neuropathy peripheral, Pain, Pain in extremity, Pyrexia
Clinical narrative: First week pain and fever.  Then pain in my legs.  Over the months I progressively got sicker.  Stage three neuropathy,  fibromyalgia, extreme fatigue,  doctors did blood work and although inflammation markers were high they couldn?t find anything conclusive.  I couldn?t sleep, walk without pain and had constant headaches.  I?m still sick
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Eustachian tube obstruction, Myringotomy, Tympanometry
Clinical narrative: Right side eustachian tube blocked, leading to fluid entrapment in middle ear and subsequent loss of hearing. Treatment included lancing the eardrum, medrol, otic antibiotic and steroid drops. Still currently undergoing treatment, but as this is a second occurrence a full remission is anticipated, at least until my next COVID vaccine.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had received a Tdap from Pharmacy on 6/17/2024 and was not due for another one when he received the dose on 11/13/2024.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atypical pneumonia, Chest X-ray, Full blood count, Mycoplasma test
Clinical narrative: none right away . 2 mo later walking pneumonia
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain, Antiphospholipid antibodies, Back pain, Bacterial test, Bilirubin conjugated
Clinical narrative: Began having feelings of back pain, abdominal pain, and chest pain. After about two weeks, began vomiting and having diarrhea along with the lingering body pains. Went to the emergency room were I passed out for an extended period of time, blood pressure dropped to 50/40, required 8L of oxygen to maintain appropriate oxygen saturations, and heart rate was 185. I was transferred to the Trauma Wing of the emergency room in order to receive the care required. Received 6 bags of IV Sodium Chloride during this time as well as numerous medical tests and exams. Eventually, it was determined that I had fluid in my heart, impacting my hears ability to beat properly. I was diagnosed at that time with a Pericardial Effusion, Pleural Effusion, and Cardiac Tamponade. I had to undergo an emergency Pericardiocentesis in order to drain the fluid. Approximately 300cc of serous fluid was drained from my pericardium and a pericardial catheter was put in place to continue draining excess fluid. After this procedure I was transferred to the Critical Care Unit where the catheter remained in place for two days. Once this catheter was removed, I was transferred to the Intensive Care Unit for closer care. I remained within the hospital for about 5 days before discharge.