chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Patient received a dose of ACTHIB that was 4 days expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via medical information (Reference number- 00650269) and transmitted to Sanofi on 21-Jun-2021.  This case involves a one-year-old female patient who received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [total, once, lot number: UJ225ABA, expiry date: 23-APR-2021, other dosing details were not reported] on 27-Apr-2021 for prophylactic vaccination that was 4 days expired (expired product administered).   Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  It was a case of actual medication error de to expired vaccine used. At the time of report, reporter was requesting clinical guidance If does it need to be re-administered.   At the time of report, no adverse event was reported.  At the time of reporting, event outcome was unknown for event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: Dystonia, Inflammatory marker test, Laboratory test normal
Clinical narrative: had dystonia or dystonic reactions; Initial information was received on 22-Jun-2021 regarding an unsolicited valid serious case from a physician (GMI Inquiry number: 00652151).  This case involves a five-month-old (unknown gender) patient who experienced dystonia or dystonic reactions (dystonia) after receiving HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) 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 serious dystonia or dystonic reactions (dystonia) (unknown latency) following the administration of HIB (PRP/T) VACCINE. This event was assessed as medically significant.  The HCP stated that they ran labs on the patient and there were no inflammatory markers detected. The HCP informed that, the patient's mother was very cautious and didn't want her child to receive more than 1 vaccine in the visit. HIB (PRP/T) VACCINE [ACT-HIB] was the only vaccine administered during this visit. The HCP asked for clarification on how often these cases are reported out of 10,000 and to confirm that there were no reports associated with dystonia and ActHib in patients without inflammatory conditions.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the event outcome was unknown.  Information on batch number is requested.; Sender's Comments: This case involves a five-month-old (unknown gender) patient who experienced dystonia (unknown latency) after vaccination with ACT-HIB. The time to onset was unknown. The patient's laboratory tests showed no inflammatory markers. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity, Rash
Clinical narrative: Allergic reaction to a flu shot / Breaking out across the back of his neck; This spontaneous case was received on 15-Jun-2021 from Med Communications (reference number: SEQW21-01435), reported by other non-health professional and processed together with additional information received on 16-Jun-2021 from Med Communisation (SEQW21-01441), reported by other health professional and concerned a male adult patient. The patient was between 27-32 years old at the time of vaccination. At the time of this report, the patient was 42-year-old.   The patient was mentally handicapped. No other patient's medical history and concomitant medications were reported.  On an unknown date, 14-15 years ago as reported, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.    On an unknown date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an allergic reaction to a flu shot with breaking out across the back of his neck. It was not a drastic reaction. The care coordinator worked with the patient. The reporters would like to get information on the ingredients for the current vaccines and flu vaccine administered 14-15 years ago. The patient's mother and the patient were interested in getting the COVID shot.  On an unspecified date, the patient recovered from the event.  The reporter assessed the event as related to influenza virus vaccine polyvalent.  Company comment: The event of 'allergy to vaccine' is considered as related to influenza virus vaccine polyvalent.; Sender's Comments: The event of 'allergy to vaccine' is considered as related to influenza virus vaccine polyvalent.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Woke up 3 am with injection site/arm very swollen. Very warm .Site muscle sore.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Bad migraine in child.  Throbbing headache
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Pt reports severe HA and tinnitus on day 6-9 after immunization.  Slowly improving since day 9.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin burning sensation
Clinical narrative: Rash started on face and spread to over 70 different areas of body.  Continues to spread two weeks after vaccine.  Skin is itchy, hot to touch and burning sensation.  First treatment was Methylprednisolone dose pack for 6 days, Triamcinolone Acetonide Cream USP 0.5%, Benadryl oral.  No improvement.  Second treatment Prednisone 20MG for 5 days, Triamcinolone Acetonide Cream USP 0.5%, Benadryl oral.  Still no improvement 14 days after 2nd vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Rash erythematous, Rash papular, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: After my first shot in the left arm about 2 weeks after the shot I got a red, raised, warm, itchy rash. It lasted for about 3 days. I used hydrocortizone cream on it a few times and it went away After my second shot in the right arm. I got the same thing after 3 days, but it was not as large of an area as the first shot was.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Severe lt arm pain . Continued to get worse. Thought it woulld go away but now radiates down arm and prevents from lifting at times.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpangina, Pyrexia, Sinusitis, Stomatitis, Tongue discomfort
Clinical narrative: As noted earlier,  I had cold symptoms develop on May 21st several weeks after my first vaccine.  I had no symptoms before. I had a sunus cold that was stubborn and unresolved when I had my second vaccine on Friday June 4th. On Saturday June 5th, I noticed visual changes on my tongue and mouth sores or ulcers and soreness when eating dinner.  I went to the walk in clinic on Monday or Tuesday morning.  The NP there diagnosed me with sinusitis for the sinus infection,  and herpangina  for the mouth,  tongue,  and throat sores and rash. She gave me a prescription for antibiotics for the sinus infection,  and a lidocaine oral rinse to numb the mouth sores for one day. It's over two weeks later, and I still have sores on my tongue,  throat,  and inner cheeks.  I have a pitted tongue too which looks unsightly.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Confusional state, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Confusion-Medium, Systemic: Fever-Medium
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Confusion-Medium, Systemic: Fever-Medium
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Tachycardia-Severe
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Tachycardia-Severe
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Numbness along right arm for 1 day,k then numbness along right leg and foot for 2 weeks
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Loss of consciousness, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Mild, Additional Details: patient feell week and loss counciusness. I place it on the floor on the side and she started feeling better and recovering counciusness. I adviced to continue breathing and she follow my comands and instantly started to recover.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mouth swelling, Swelling face, Swelling of eyelid, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Mild, Additional Details: patient reported swelling in eyelids and the whole area around the eye that started wednesday 6/23; 2 days after pfizer 1st shot, pt. went to an urgent care that prescribed the patients triamcinolone 0.025% cream to apply to affected area. pt reported swelling reduction after treatment but on friday that the right eye started to swell up as well but not as bad as the left. no vision changes has been reported, Pt is to follow up with an eye doctor next week.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dreamy state, Flushing, Gait disturbance, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient reported feeling in a dream like state and woke up to me holding him.  Pharmacist on duty was holding him to keep him steady/not fall over.  Had pulse and respiration was normal, BP was 127/92.  Technician called 911 while pharmacist was observing patient.   EMS arrived to take patient for observation outside of facility.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient reported feeling in a dream like state and woke up to me holding him.  Pharmacist on duty was holding him to keep him steady/not fall over.  Had pulse and respiration was normal, BP was 127/92.  Technician called 911 while pharmacist was observing patient.   EMS arrived to take patient for observation outside of facility.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: Error: Diluent Administered Instead of Vaccine-
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, chill, headache
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient became lightheaded approximately 14 minutes after COVID19 vaccine administration, patient was still sitting in exam chair. Laid patient back to 45 degrees on exam table, gave glucose tablet, patient BP 90/60, HR90, RR16, O2 98% states has "syncope" and happens once every 2-3 months, states does not think related to COVID19 vaccine, given water and salty chips per patient request. Patient BP 100/60, HR 70, RR16, O298% after 4 minutes. Patient called mom to drive her home.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: sharp chest pain and shortness of breath. on and off since 1st dose-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Additional Details: She states that some of her chest pain is sharp and causes shortness of breath. She had to take a break at work and sit for 30 minutes. She is going to have appointment with PCP to check it out before her 2nd dose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted post-vaccination while sitting in a chair during her observation time.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Nausea, Seizure, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Medium, Additional Details: patient collapsed after feeling very nauseated about 24 hours after having vaccine. wife reported tensing of all muscles and patient laid back on stairs, lasted about a minute then subsided
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Medium, Additional Details: patient collapsed after feeling very nauseated about 24 hours after having vaccine. wife reported tensing of all muscles and patient laid back on stairs, lasted about a minute then subsided
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Feeling hot, Musculoskeletal stiffness
Clinical narrative: My arm is stiff and has pain in the joint when I reach for something. I also want to report my right hip joint bone crackle and felt like it pop out of place. My heart feels like it is cooking on simmer at times. I feel something so different than I felt before.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Injection site pain, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient was sitting in chair and fainted approx 5 mins after vaccination. His mother got my attention after he picked himself off the floor. Pt reported blacking out and falling on the carpet. He had a small bruise with a little bleeding (from carpet burn). His mother gave him water and I got him some paper towels to wipe off the small amount of blood on forehead.  I asked pt if history of fainting and he said yes.  He said he didn't mention it because the more it is discussed, the worse it is.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Rash papular, Tenderness
Clinical narrative: 2? round raised mark with redness in 3/4 of the lump. Tender to the touch.  I received Astro Zeneca lot number NA 0079 as my first dose on April 15, 2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site mass, Tenderness
Clinical narrative: Fatigue, lump at injection site, arm tenderness
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate irregular, Influenza like illness, Pyrexia
Clinical narrative: Starting at 11pm only 6 hours after shot I began flu like symptoms. From 1am to 2am I had uncontrollable body shivers and pounding headache worst I?ve ever experienced . Had to take hot shower for 40 minutes to regulate body temp and stop shivers. Pulse had been at 114 from 1am- 4am (normally around 85). Took ibprofen for headache.. 20 hours after shot had 104.4 fever and 112 pulse - extreme headache persisting now for 30 hours - high  fever coming and going - taking Tylenol and Ibprofen? headache will not go away. Feeling flu like still 30 hours after shot.  Pulse is fluctuating between 85 and 115 depending on sleep/rest/medication. This is the worst illness I?ve ever encountered. Headache is unbearable.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fall, Seizure, Tremor
Clinical narrative: Had seizure. Fell in shower, started shaking uncontrollably, had difficulty breathing. He had a seizure for the first time in his life 6 days after first dose (already reported). This one was his second seizure ever.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Fatigue, Hypoaesthesia, Lung disorder
Clinical narrative: Approximately a week and a half after my second Covid vaccine, I began to have pins-and-needles sensation in my toes. It was subtle at first, making it hard for me to pin down exact day. I did note for sure, while driving to an appointment, on the morning of 2/17/21 that I did have this pins-and-needles and numb sensation in all my toes, bilaterally. It continued over the next weeks. The sensation was persistent with pins and needles to toes and somewhat to balls of feet, numbness to the tips of my toes. After about 2 weeks of this, I began to have slight numbness to the tips of my fingers with intermittent tingling surges through my hands. After 3 weeks of this not getting better, I started to become concerned.  I do have an undifferentiated connective tissue disorder and was on Arava (leflunomide) at that time (started October 2020). I called my rheumatologist as I thought it might be related to my disease process or medication and had a visit with her 3/19/21. They were not sure of the connection with leflunomide, but stopped the medication due to other issues (persistently low blood counts). I was started on Plaquenil at that time. I started a B vitamin supplement as well, as low vitamin B can be related to small fiber neuropathy. Since that time, my neuropathy has continued in my toes with worsening numbness. I am not diabetic. The plan now is for me to have biopsies of my ankle, calf and thigh, to be performed at my next rheumatology visit in July.  Also, I had Covid end of October, and was quite ill. I am still dealing with quite a few long covid symptoms that both my primary care physician and my rheumatologist are trying to sort out: intermittent chest pain, fatigue, ongoing diarrhea, lung nodules and granularity. This has made the diagnosis of the neuropathy more complicated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Paraesthesia
Clinical narrative: Approximately a week and a half after my second Covid vaccine, I began to have pins-and-needles sensation in my toes. It was subtle at first, making it hard for me to pin down exact day. I did note for sure, while driving to an appointment, on the morning of 2/17/21 that I did have this pins-and-needles and numb sensation in all my toes, bilaterally. It continued over the next weeks. The sensation was persistent with pins and needles to toes and somewhat to balls of feet, numbness to the tips of my toes. After about 2 weeks of this, I began to have slight numbness to the tips of my fingers with intermittent tingling surges through my hands. After 3 weeks of this not getting better, I started to become concerned.  I do have an undifferentiated connective tissue disorder and was on Arava (leflunomide) at that time (started October 2020). I called my rheumatologist as I thought it might be related to my disease process or medication and had a visit with her 3/19/21. They were not sure of the connection with leflunomide, but stopped the medication due to other issues (persistently low blood counts). I was started on Plaquenil at that time. I started a B vitamin supplement as well, as low vitamin B can be related to small fiber neuropathy. Since that time, my neuropathy has continued in my toes with worsening numbness. I am not diabetic. The plan now is for me to have biopsies of my ankle, calf and thigh, to be performed at my next rheumatology visit in July.  Also, I had Covid end of October, and was quite ill. I am still dealing with quite a few long covid symptoms that both my primary care physician and my rheumatologist are trying to sort out: intermittent chest pain, fatigue, ongoing diarrhea, lung nodules and granularity. This has made the diagnosis of the neuropathy more complicated.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Joint range of motion decreased, Loss of personal independence in daily activities, Pain
Clinical narrative: On January 7th, I complained to a doctor about right arm elbow pain.  She told me to keep an eye on it. I had a telehealth visit on January 13th d/t worsening pain, had a negative x-ray that day. The pain became much more severe and I was unable to do the following ADLs without significant pain: pick up my daughter (< 30 lbs), roll over in bed, turn on the shower, pick up a heavy pan, pick up my purse to put it on my right shoulder, boost patients at work, fully extend/flex my right arm.  At PCP's recommendation, I started seeing a PT 3x/week on February 2nd. She found reduced ROM and strength in right arm, unable to fully flex/extend. Unfortunately, traditional PT increased my pain, spread to right shoulder and back, all related to elbow per PT. I tried CBD cream (at PCP's recommendation), OTC pain meds, daily PT exercises/stretching, pain meditations, acupuncture, and massage, none of which improved pain. I eventually needed a prescription for a muscle relaxer to be able to work, which was very distressing, as it required pausing attempts to conceive. I found a great deal of relief with a PT who did myofascial relief, but due to multiple scheduling issues I was unable to get on the caseload of a PT who specialized in this. I eventually abandoned PT, as it did not help (and made things worse), spent over $500 out of pocket on PT alone (not to mention all the other significant costs). I finally found some relief from seeing a chiropractor, was able to discontinue muscle relaxers. Right arm pain is still not fully resolved, 6 months later. I can do ADLs again, occasional pain, strength and ROM are still reduced.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: On January 7th, I complained to a doctor about right arm elbow pain.  She told me to keep an eye on it. I had a telehealth visit on January 13th d/t worsening pain, had a negative x-ray that day. The pain became much more severe and I was unable to do the following ADLs without significant pain: pick up my daughter (< 30 lbs), roll over in bed, turn on the shower, pick up a heavy pan, pick up my purse to put it on my right shoulder, boost patients at work, fully extend/flex my right arm.  At PCP's recommendation, I started seeing a PT 3x/week on February 2nd. She found reduced ROM and strength in right arm, unable to fully flex/extend. Unfortunately, traditional PT increased my pain, spread to right shoulder and back, all related to elbow per PT. I tried CBD cream (at PCP's recommendation), OTC pain meds, daily PT exercises/stretching, pain meditations, acupuncture, and massage, none of which improved pain. I eventually needed a prescription for a muscle relaxer to be able to work, which was very distressing, as it required pausing attempts to conceive. I found a great deal of relief with a PT who did myofascial relief, but due to multiple scheduling issues I was unable to get on the caseload of a PT who specialized in this. I eventually abandoned PT, as it did not help (and made things worse), spent over $500 out of pocket on PT alone (not to mention all the other significant costs). I finally found some relief from seeing a chiropractor, was able to discontinue muscle relaxers. Right arm pain is still not fully resolved, 6 months later. I can do ADLs again, occasional pain, strength and ROM are still reduced.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Musculoskeletal chest pain
Clinical narrative: Chest pain and rib pain lasting about 3 hours. Tylenol was taken.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm, Dizziness, Loss of consciousness, Somnolence, Unresponsive to stimuli
Clinical narrative: We were sitting in the after-shot waiting area for the mandatory 15 minute wait period. Patient was getting restless and started asking to leave ~13 minutes after shot. I said ?no, we need to wait the full 15 minutes they recommend?. About on minute later, or ~14 minutes after shot, Patient said he felt like he was going to pass out. As I turned my head to look at him to began to slump towards me unconscious and I held him up by his shoulder and waved the paramedics over. He was unconscious with eyes closed for about 5 seconds and by the time the paramedics got there his eyes were fluttering, but he remained unresponsive for another ~10-15 seconds as they were calling his name, tapping his shoulder, and asking him questions. Then he finally came around and, while groggy, he was able to answer questions. He sat there a couple minutes talking to paramedics and they had wheelchair, but he said he could walk and got up slowly to walk slowly back to clinic area.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound scan abnormal, X-ray limb normal
Clinical narrative: Starting on or about June 16th  - slight swelling noticed in left ankle, and left calf.   Swelling continued in left ankle and left calf even after ice and elevating foot.   June 21st scheduled doctor appointment with orthopedic thinking perhaps leg or ankle injury.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysphagia, Fatigue, Impaired work ability, Injection site pruritus
Clinical narrative: I began itching at the injection site around 10 am. It then began to spread down my arm and into both sides of my rib cage.  It kept spreading up my throat, across my chest and neck and down to my legs. I could not stop scratching. About the time my neck started itching, my throat started feeling weird and tight. I could not swallow easily. I was given Benadryl, famotidine, Solu-Medrol, Zyrtec and epinephrine. My symptoms would slow for a moment and then continue. I was sent to Holy Family Emergency room from urgent care due to my severe allergic reaction to the vaccine. I was given some of the same medications but they also eventually added Vistaril. I was eventually discharged late that night. I did have a rebound reaction between 2-3 am the next morning with new hives developing and a feeling of tightness/inability to swallow returning. I have had the itching and hives return several times this past week and still have visible hives. I feel weak and tire easily. I have missed some work because of this. With times being hard as it is, that isn't good. I was trying to be a good citizen.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation, Throat tightness, Urticaria, Vaccination complication
Clinical narrative: I began itching at the injection site around 10 am. It then began to spread down my arm and into both sides of my rib cage.  It kept spreading up my throat, across my chest and neck and down to my legs. I could not stop scratching. About the time my neck started itching, my throat started feeling weird and tight. I could not swallow easily. I was given Benadryl, famotidine, Solu-Medrol, Zyrtec and epinephrine. My symptoms would slow for a moment and then continue. I was sent to Holy Family Emergency room from urgent care due to my severe allergic reaction to the vaccine. I was given some of the same medications but they also eventually added Vistaril. I was eventually discharged late that night. I did have a rebound reaction between 2-3 am the next morning with new hives developing and a feeling of tightness/inability to swallow returning. I have had the itching and hives return several times this past week and still have visible hives. I feel weak and tire easily. I have missed some work because of this. With times being hard as it is, that isn't good. I was trying to be a good citizen.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: I experienced expected injection site tenderness in my arm and body aches, headache, and chills the following day (after administration of my 2nd dose) starting around 10 AM that tapered off by the following day. However, my concern has been for on-going, intermittent, continued pain and swelling of the lymph nodes near my left arm pit.  At times  it feels as if there is a hard lump in my armpit.  I?ve had 3-4 episodes of this since receiving my second dose of the vaccine.  Never in my life, prior to receiving the vaccine have I ever had this experience and I am currently in better health than I have been in years.  It is clear to me that o set was definitely after receiving the 2nd vaccine and would not be better explained by anything else in my daily routine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I experienced expected injection site tenderness in my arm and body aches, headache, and chills the following day (after administration of my 2nd dose) starting around 10 AM that tapered off by the following day. However, my concern has been for on-going, intermittent, continued pain and swelling of the lymph nodes near my left arm pit.  At times  it feels as if there is a hard lump in my armpit.  I?ve had 3-4 episodes of this since receiving my second dose of the vaccine.  Never in my life, prior to receiving the vaccine have I ever had this experience and I am currently in better health than I have been in years.  It is clear to me that o set was definitely after receiving the 2nd vaccine and would not be better explained by anything else in my daily routine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Headache
Clinical narrative: Heaviness in chest; heart flutters; headaches.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Ventricular extrasystoles
Clinical narrative: Heart PVC.S
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Blood test, Menstrual disorder
Clinical narrative: After the second dose of the Moderna mRNA vaccine, I became amenorrheic for two months, followed by a three-week period. Prior to the vaccine, I was completely regular with a 28 day cycle. My cycle is still inconsistent and I had my hormone levels tested in an attempt to restore balance.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: immediately felt lightheaded, dizzy, sweaty. resolved momentarily
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid heart beat for about 4 hours. The next day had same for about 1 hour. Fine after that.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site erythema, Oedema peripheral
Clinical narrative: Visible swollen area under armpit (axilla).  Larger than single lymph node. Pain currently 2-3/10.   Also, beginning day 2 (Saturday 0800), 3 flat red areas just below injection site on anterior dorsal medial side of left arm.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dyspepsia
Clinical narrative: Indigestion and heart burn the following day after 2nd vaccine, to the point I went across the street to urgent care and sat in their parking lot, not knowing if It was a heart attack or indigestion.  After 15 minutes the symptoms subsided and I was able to leave. Both symptoms will still occur occasionally today which I treat with Tums.  Prior to the vaccine, I have never experienced those symptoms.  I also had loss of taste for exactly 1 week starting the day after the 2nd vaccine.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Hypoacusis, Tinnitus
Clinical narrative: tinnitus, continuous high pitch ringing in left ear with hearing loss at certain high frequencies.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast swelling, Lymphadenopathy, Menstrual disorder, Menstruation irregular
Clinical narrative: Swollen lymph nodes in upper neck and breasts 15 hours after shot. Breasts nodes still swollen. Neck nodes go up and down. Menstrual cycle 10 days after shot. Prior to both doses, cycle was EXTREMELY irregular. Could go anywhere from 67-139 days between cycles. This was 32 days. Shortest cycle I?ve had.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Palpitations
Clinical narrative: rapid heart beat, heart pounding overall tiredness, still experiencing
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: 36 hours after my second shot, I experienced severe pain in a lower right molar.  I could not bite down on that tooth and it got worse in the next two days. I finally went to the dentist who looked at an exray of the area (it is a crowned molar) but could not see anything.  He gave me an antibiotic and I scheduled a followup appt with a specialist.  After a few days on the antibiotic, the pain subsided. At my follow up appt., the dr. tested the tooth for pressure and cold reaction, but all of this was negative.  I thought I was going to face getting a root canal but she could find nothing wrong with the tooth/root.  By the end of that week, I was almost pain free, but even now, 3  months later, I feel as if that tooth/root has been compromised.  I am convinced that it was caused by the covid vaccination.  FYI, I had a mild case of covid19 in March 2020.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Flushing, Paraesthesia
Clinical narrative: Client 5 minutes after receiving Pfizer  1 st dose vaccine  client felt lightheaded. Client laid down to floor supine and was awake and alert. Client face was flushed and client appeared anxious--HR 80bpm. Client's extremities cool and client reported tongue was swelling and bilateral arms were tingling. Epi pen 0.3 mg IM administered in left thigh and 911 called. Client remained alert until paramedics arrived--breathing labored and hands clenched down. Mother at side
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, Swollen tongue
Clinical narrative: Client 5 minutes after receiving Pfizer  1 st dose vaccine  client felt lightheaded. Client laid down to floor supine and was awake and alert. Client face was flushed and client appeared anxious--HR 80bpm. Client's extremities cool and client reported tongue was swelling and bilateral arms were tingling. Epi pen 0.3 mg IM administered in left thigh and 911 called. Client remained alert until paramedics arrived--breathing labored and hands clenched down. Mother at side
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Computerised tomogram, Echocardiogram, Laboratory test, Magnetic resonance imaging
Clinical narrative: Started having TIA?s not sure if related but seems suspect when I have never had anything like that before the vaccine
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Started having TIA?s not sure if related but seems suspect when I have never had anything like that before the vaccine
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Condition aggravated, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Pain in left bicep initially. :Pain and stiffness gradually spread to both shoulders, both hips, and both wrists. Increasing pain and stiffness. Diagnosed with :PMR (polymyalgia rheumatica) Began treatment with :Prednisone
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Physical examination, Polymyalgia rheumatica
Clinical narrative: Pain in left bicep initially. :Pain and stiffness gradually spread to both shoulders, both hips, and both wrists. Increasing pain and stiffness. Diagnosed with :PMR (polymyalgia rheumatica) Began treatment with :Prednisone
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever of 102 degrees F, chills, nausea; approximately 48 hours
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Within three days after the second shot, I started having headaches. Noting that I never get headaches. But every day after the second shot they have increased in severity. Now seems like I have a headache all day long and it's quite debilitating. Should I reach out to my doctor? I did have a change in my hormone replacement therapy prescription right around the same time. Insurance refuse to cover my prempro, and put me on Jinteli. Other than that change everything has remained the same.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Mother () brought  into our pharmacy to receive a COVID-19 vaccine. Mom filled out the VAR (Vaccine Administration Record) with a . Her first immunization in this series of two was administered on 05/13/2021. According to the paperwork mom filled out,  was 12 years old at the time. After entering the vaccine data into our state's immunization reporting system (, we received a phone call from a  representative stating the child was under the age of 12 at the time of immunization. I contacted the child's PCP to inquire what date of birth they had on record. They stated they had  thus making the child only 11 years old at the time of immunization. I called the mom  to discuss. She stated that she had lied on the form so her daughter could obtain a vaccine because she was desperate. She stated that her mom (Grandma) lives in  and was diagnosed with terminal cancer during the COVID-19 pandemic. She stated that her family had not been able to see Grandma in over a year, and now Grandma had entered into palliative care / hospice. Grandma's oncologist told  she would not be able to have her family visit with Grandma unless the entire family was vaccinated. Out of desperation,  chose to be untruthful about her daughter's date of birth so her daughter  could be vaccinated and her family could go visit Grandma in . I inquired about  tolerance of the vaccine and whether or not she had experienced any side effects.  stated she had tolerated it fine with no adverse effects that she had noticed. She apologized and stated that she will be upfront and honest with any  representative or other health care provider who contacts her regarding this situation.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling cold, Headache, Joint swelling
Clinical narrative: Get tire extremely fast when walking daily Shortness of breath daily  Swollen ankles daily  Headaches every morning when I wake up Pressure in left eye often Body was cold the night of the vaccine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: Get tire extremely fast when walking daily Shortness of breath daily  Swollen ankles daily  Headaches every morning when I wake up Pressure in left eye often Body was cold the night of the vaccine
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site warmth
Clinical narrative: AE: patient felt warm pain on the right arm after 1 minute of  vaccine administration. As per the patient, never  felt this kind of pain before. there was no numbness, no tingling. it did not hurt upon palpitation.  Treatment: patient was offered water to drink and kept under observation. Approximately 10 minutes after observation, patient symptoms improved.  Outcome: Patient was discharged to POV/Home.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Impaired driving ability, Swollen tongue
Clinical narrative: Swelling of tongue. Started on the right side in two hours the entire tongue was swollen. Resumed all medications as prescribed and have not had similar reactions. The only variant was the fact I had the second vaccine three days prior to swelling. I also could not see well while driving and was fatigued and disoriented for about 14 days after my second dose of Phizer.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: I started spotting 10 days before my period was supposed to come. I'm currently in my period now and don't know when I'll stop bleeding.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature increased, Chills, Diarrhoea
Clinical narrative: Day 1 104 degree temperature, nausea, vomiting, diarrhea, chills, muscle aches, loss of taste and smell. Day 2-Day 9 severe muscle pain in back when standing or walking.  Fatigue, nausea. Day 10-14 Fatigue, tremors, nausea ( Day 12 - severe headache, diarrhea).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, SARS-CoV-2 test negative, Tremor
Clinical narrative: Day 1 104 degree temperature, nausea, vomiting, diarrhea, chills, muscle aches, loss of taste and smell. Day 2-Day 9 severe muscle pain in back when standing or walking.  Fatigue, nausea. Day 10-14 Fatigue, tremors, nausea ( Day 12 - severe headache, diarrhea).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Day 1 104 degree temperature, nausea, vomiting, diarrhea, chills, muscle aches, loss of taste and smell. Day 2-Day 9 severe muscle pain in back when standing or walking.  Fatigue, nausea. Day 10-14 Fatigue, tremors, nausea ( Day 12 - severe headache, diarrhea).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram ST segment abnormal, Laboratory test, Troponin increased
Clinical narrative: chest pain, elevated troponin, ST segment changes on EKG
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nervousness
Clinical narrative: AE: patient feeling light headed and dizzy upon vaccine administration. Patient states that she has not eaten anything this morning prior to the vaccine. Patient also states that she feels nervous and sweaty. Treatment: patient was placed on the Trendelenburg position as well as offered water and crackers. after few minutes, patient stated she no longer feels light-headed or dizzy. outcome: Patient was discharged to /Home.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lack of injection site rotation
Clinical narrative: Pain at injection site that lingers, minor but noticeable loss of rotational ability in upper left arm
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Inflammation, Pain in extremity, Psoriasis
Clinical narrative: Severe arthritis symptoms. I have psoriasis and suspect shot caused inflammation, a psoriasis trigger.  Never had arthritis in arms, now it's difficult to dress.  Started right after second shot.  Taking Tylenol but it doesn't help a lot. Hip pain as well, and right thumb. Knees had arthritis, but are worse now.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pharyngeal paraesthesia, Throat irritation
Clinical narrative: Near end of patient's 15 minute post-vaccine wait period, patient reported feeling slightly dizzy. Patient was seated then stood to notice. Patient took own BG with own meter, documented WNL for patient.(122g/dL). Patient was then instructed to be seated with feet elevated to monitor. Patient took own pulse, reported at 70bpm., WNL for patient fitness level.  During continued time seated, about 15 more minutes, patient reported that her throat "felt funny" or tingling. Patient was then given 37.5mg liquid diphenhydramine and driven to nearest healthcare facility with NP/MD- Urgent Care(7 miles away). Once there, patient seen by NP on duty, assessed( BP taken140/80), monitored, and released without further concern. No treatment given at UC. Patient not required to resume work same day, so was driven home by family member. Follow up: reported to work without concern next AM.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Dizziness, Fatigue, Headache
Clinical narrative: Low fever (100-101) within first 2 hours, held for 9 hours, then lowered to 99 for approx. 10 hours.  Back to 97.8 by 23 hours after injection.  (5 hours after injection, took 2 Ibuprofen, 200mg)  Moderate dizziness, fatigue and frontal headache for 15 hours, beginning 2 hours after injection.  Moderate asthma symptoms, 2.5 hours after injection: wheezing, cough, etc. (Used nebulizer and albuterol solution 1x., 6 hours after injection. Continued maintenance inhaler, Flovent, 2x a day, as usual)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Wheezing
Clinical narrative: Low fever (100-101) within first 2 hours, held for 9 hours, then lowered to 99 for approx. 10 hours.  Back to 97.8 by 23 hours after injection.  (5 hours after injection, took 2 Ibuprofen, 200mg)  Moderate dizziness, fatigue and frontal headache for 15 hours, beginning 2 hours after injection.  Moderate asthma symptoms, 2.5 hours after injection: wheezing, cough, etc. (Used nebulizer and albuterol solution 1x., 6 hours after injection. Continued maintenance inhaler, Flovent, 2x a day, as usual)
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever over 101.0, vomiting, body aches, chills, described as very bad pounding headache.    Fever began at approximately 10:00 pm 6/23 same day as vaccination. vomiting began approximately 2 am ending by morning.  Fever chills headache continued until 6/25.   Conditions subsided by the evening of 6/25. Minimal effects by bedtime, tired, some body aches.   Extra strength Tylenol was used for treatment
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Gastric haemorrhage, Hypertensive crisis, Internal haemorrhage, Intestinal haemorrhage
Clinical narrative: Crisis Hypertension, Thrombocytopenia with internal bleeding from stomach and intestines  (replaced 4 pints of blood), shortness of breath.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytopenia, Transfusion
Clinical narrative: Crisis Hypertension, Thrombocytopenia with internal bleeding from stomach and intestines  (replaced 4 pints of blood), shortness of breath.