chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site, Sleep disorder, Tendon disorder, Tendon rupture, Tendonitis
Clinical narrative: -Intense burning and pain immediately upon injection -Noticed injection given higher up on arm than ever previously -Intensifying soreness over next several days. Started using Aleve and Motrin with some effect for next week or so for soreness and pain. -During this time soreness/pain started limiting movement of left arm -During second week of November intense overwhelming sharp pain/cramping in shoulder/arm while putting on jacket and whenever with shrugging motion. -Next several days same type of pain when left arm was bent in certain positions or while reaching for something/extending arm or while putting pressure on shoulder.  Difficulty bathing while washing hair or back, difficulty getting dressed/undressed, unable to sleep on left side -Began to use Salonpas patches and heating pads to help alleviate pain. - November 19th 2022: Contacted primary MD and was referred to contact a ortho specialist. -November 20th 2022 went to local urgent care and was told to give it more time and increase dosage of Motrin.  MD ordered one week supply of Flexeril, taken as ordered with minimal/no effect.  Began to use ICY HOT, helped somewhat.  MD states likely vaccine reaction. -Had vacation time for Thanksgiving week and used it to rest shoulder/arm. -December 2nd went to see ortho/shoulder specialist at urgent care:  X-rays done which did not show anything.  Diagnosed with tendonitis of left rotator cuff and bursitis.  Treated with US guided cortisone injection with some relief afterwards.  Advised on exercises to perform.  MD states post-vaccination reaction, sequela. -December 2nd : Advised place of employment of situation and told to file claim.  As urgent does not accept claim insurance will need to change provider.  New provider chosen affiliated with workplace Hospital.  Out of work letter by MD provided to employer. -December 27th visit to new ortho/shoulder specialist: X-rays done, MRI ordered, told to continue current regimen of NSAIDs, ICY HOT, heat/massage, exercises, and newly started CBD.  Out of work letter received. Temporary disability for regular work 100%.  MD states possible SIRVA following flu injection 10/24/2022. -February 6th 2023 follow up visit with ortho/shoulder MD: reviewed MRI results, continue out of work letter received, order for physical therapy. MD states will try PT otherwise may need surgery.  Will follow up with MD in approximately 6 weeks.  New out of work letter received. Temporary disability for regular work 100%.  MD states possible SIRVA. -February 21st first visit with PT with small amount of relief during session.   -February 22nd:  intense pain/cramping continues in left shoulder/arm especially while reaching/extending left arm/shoulder and compressing/bearing weight left arm/shoulder. Difficulty sleeping due to difficulty in maneuvering while in bed and unable to sleep on left side.  Will try to use special pillow.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Tenosynovitis, Weight bearing difficulty, X-ray limb normal
Clinical narrative: -Intense burning and pain immediately upon injection -Noticed injection given higher up on arm than ever previously -Intensifying soreness over next several days. Started using Aleve and Motrin with some effect for next week or so for soreness and pain. -During this time soreness/pain started limiting movement of left arm -During second week of November intense overwhelming sharp pain/cramping in shoulder/arm while putting on jacket and whenever with shrugging motion. -Next several days same type of pain when left arm was bent in certain positions or while reaching for something/extending arm or while putting pressure on shoulder.  Difficulty bathing while washing hair or back, difficulty getting dressed/undressed, unable to sleep on left side -Began to use Salonpas patches and heating pads to help alleviate pain. - November 19th 2022: Contacted primary MD and was referred to contact a ortho specialist. -November 20th 2022 went to local urgent care and was told to give it more time and increase dosage of Motrin.  MD ordered one week supply of Flexeril, taken as ordered with minimal/no effect.  Began to use ICY HOT, helped somewhat.  MD states likely vaccine reaction. -Had vacation time for Thanksgiving week and used it to rest shoulder/arm. -December 2nd went to see ortho/shoulder specialist at urgent care:  X-rays done which did not show anything.  Diagnosed with tendonitis of left rotator cuff and bursitis.  Treated with US guided cortisone injection with some relief afterwards.  Advised on exercises to perform.  MD states post-vaccination reaction, sequela. -December 2nd : Advised place of employment of situation and told to file claim.  As urgent does not accept claim insurance will need to change provider.  New provider chosen affiliated with workplace Hospital.  Out of work letter by MD provided to employer. -December 27th visit to new ortho/shoulder specialist: X-rays done, MRI ordered, told to continue current regimen of NSAIDs, ICY HOT, heat/massage, exercises, and newly started CBD.  Out of work letter received. Temporary disability for regular work 100%.  MD states possible SIRVA following flu injection 10/24/2022. -February 6th 2023 follow up visit with ortho/shoulder MD: reviewed MRI results, continue out of work letter received, order for physical therapy. MD states will try PT otherwise may need surgery.  Will follow up with MD in approximately 6 weeks.  New out of work letter received. Temporary disability for regular work 100%.  MD states possible SIRVA. -February 21st first visit with PT with small amount of relief during session.   -February 22nd:  intense pain/cramping continues in left shoulder/arm especially while reaching/extending left arm/shoulder and compressing/bearing weight left arm/shoulder. Difficulty sleeping due to difficulty in maneuvering while in bed and unable to sleep on left side.  Will try to use special pillow.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Flu-like symptoms for about 3 days as well as very sore arm at injection site.  On day 5 a rash appeared that was very itchy md warm to touch about 4-5 inches long and 2 inches across at injection site.  Arm still very tender as of day 5.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin warm, Tenderness
Clinical narrative: Flu-like symptoms for about 3 days as well as very sore arm at injection site.  On day 5 a rash appeared that was very itchy md warm to touch about 4-5 inches long and 2 inches across at injection site.  Arm still very tender as of day 5.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: AT 1220, PT REPORTED PRESSURE STARTING FROM L ARM AND SPREADING TO R ARM AND LOWER EXTREMITIES. at 1220 PT's WERE STABLE, BP 130/70, PULSE 68, 22 RESPIRATIONS/MIN; PT REPORTED NO OTHER SYMPTOMS. NURSES MONITORED PT FOR 30 MINS. AT 1255, PT REPORTED NO ADDITIONAL SYMPTOMS. AT 1255, PT'S VITALS CONTINUED TO BE STABLE, BP 140/85, PULSE 70. PER PT, THE PRESSURE WAS GONE BY THE END OF MONITORING PERIOD. NURSES RECOMMENDED PT TO FOLLOW UP WITH PCP
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Nasopharyngitis, Pain
Clinical narrative: Headache, glands hurt, fatigue, cold, insomnia.
Age: 89.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Cerebrovascular accident, Fall, Fatigue, Gait disturbance, Gait inability
Clinical narrative: October 27th started with extreme fatigue,  difficulty walking, unable to preform usual ADL's.  November 2nd had fall due to stroke, liver laceration, subarachnoid hemorrhage.  Continued L sided weakness, unable to walk on own, needs help with all ADLS-Tranferred to assisted living.
Age: 89.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Hemiparesis, Imaging procedure, Laboratory test, Loss of personal independence in daily activities, Subarachnoid haemorrhage
Clinical narrative: October 27th started with extreme fatigue,  difficulty walking, unable to preform usual ADL's.  November 2nd had fall due to stroke, liver laceration, subarachnoid hemorrhage.  Continued L sided weakness, unable to walk on own, needs help with all ADLS-Tranferred to assisted living.
Age: 89.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Traumatic liver injury
Clinical narrative: October 27th started with extreme fatigue,  difficulty walking, unable to preform usual ADL's.  November 2nd had fall due to stroke, liver laceration, subarachnoid hemorrhage.  Continued L sided weakness, unable to walk on own, needs help with all ADLS-Tranferred to assisted living.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Impaired work ability
Clinical narrative: Experienced muscle pain, intense headache, shivering, fever, and extreme tiredness (had to call out sick from work on the second day and slept about 14 hours that day)
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Experienced muscle pain, intense headache, shivering, fever, and extreme tiredness (had to call out sick from work on the second day and slept about 14 hours that day)
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Laboratory test abnormal, Vertigo
Clinical narrative: Starting in February 2022 I started to have serious vertigo attacks.  3 in Feb. 2022, then one a month until June 2022.  In June I started have many each month: 7 in July and 5 in September.  They have been fewer and milder in 2023.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electroencephalogram normal, Generalised tonic-clonic seizure, Magnetic resonance imaging normal, Photophobia
Clinical narrative: Two grand mail seizures 22 days after booster vaccine. Been on anti seizure meds since. Experiencing dizziness, bright light and strobe lights now make me dizzy and I have to wear sunglasses all the time now and remove myself whenever I see strobe lights.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient requested Moderna Bivalent Booster vaccine received from the pharmacy a medicine container with Moderna vaccine vial and the handwritten label read: Moderna Bivalent, Lot 063B22A, with expiration date 03/02/2023, out of freezer 0950 am, 2/22/2023. Inside the medication container was a Moderna Monovalent vaccine vial. RN administered 0.50ml Moderna monovalent covid-19 vaccine instead of the recommended bivalent Moderna vaccine. As soon as RN noticed the error, patient was immediately notified that he received Moderna COVID-19 monovalent booster instead of COVID-19 bivalent booster, patient was monitored for 15 minutes, no adverse reaction was noted advised patient to report any delayed reaction to RN, pt verbalized understanding.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Persistent pain in right shoulder joint. Treated with over the counter non-steroidal anti-inflammatory medication. Pain still persists.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Rash, Rash erythematous, Swelling
Clinical narrative: I have a large rash on my abdomen. The size of a baseball. I went to the local clinic. They could not confirm what it was. I called the center and they told me could not possibly be caused by the shot. It burns and is very painful and very red and swollen.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Diarrhoea, Extra dose administered, Fatigue, Hyperhidrosis
Clinical narrative: I was administered the PPSV23 Pneumococcal Vaccination on February 9, 2023 and the Shindrix Vaccine. One in right arm and one in left arm. They incorrectly administered the PPSV23 as I had already received this vaccine both of thhe PPSV23 and Shindrix Vaccine in August of 2022. I tried to tell them that I already had both shots, but the nurse kept showing me the shots were not recorded in the comuter in August. In fact, I did recieve both shots in August and the doctor confirmed it and said that it was not correctly documented in the computer.. I was told that this was a mistake and the nurse in August had failed to enter that they administered both shots in August. This is the second time this has happened. In 2016, the clinic had administered the Prevnar 20 shot six months after I had already received it at another Facility. I told them that I had gotten it already and they insisted that it was a different shot, but in fact it was the same shot and it made me very ill right away. At that time, I had severe selling in my right arm, that caused significant lymphoedema that has not yet resolved. In addition, I was quite shocked that they administered the shot in the shoulder muscle that has a tear with a 4 mm retraction, and I had just gotten the steroid shot the week prior in that shoulder. I had reported the error, before, but I am now doubting that it was reported and addressed as they are making the same mistakes. Two weeks out, I have extreme fatigue and weakness. I have been having sweats. My pain level is greatly increased. I had extreme diarrhea, very significant pain my arm and as weel throughout my body. I have significant malaise.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Lymphoedema, Malaise, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: I was administered the PPSV23 Pneumococcal Vaccination on February 9, 2023 and the Shindrix Vaccine. One in right arm and one in left arm. They incorrectly administered the PPSV23 as I had already received this vaccine both of thhe PPSV23 and Shindrix Vaccine in August of 2022. I tried to tell them that I already had both shots, but the nurse kept showing me the shots were not recorded in the comuter in August. In fact, I did recieve both shots in August and the doctor confirmed it and said that it was not correctly documented in the computer.. I was told that this was a mistake and the nurse in August had failed to enter that they administered both shots in August. This is the second time this has happened. In 2016, the clinic had administered the Prevnar 20 shot six months after I had already received it at another Facility. I told them that I had gotten it already and they insisted that it was a different shot, but in fact it was the same shot and it made me very ill right away. At that time, I had severe selling in my right arm, that caused significant lymphoedema that has not yet resolved. In addition, I was quite shocked that they administered the shot in the shoulder muscle that has a tear with a 4 mm retraction, and I had just gotten the steroid shot the week prior in that shoulder. I had reported the error, before, but I am now doubting that it was reported and addressed as they are making the same mistakes. Two weeks out, I have extreme fatigue and weakness. I have been having sweats. My pain level is greatly increased. I had extreme diarrhea, very significant pain my arm and as weel throughout my body. I have significant malaise.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Asthenia, Cardiac failure, Cardiac monitoring, Cardiac stress test
Clinical narrative: On 2/16/2021, one week after receiving dose 1, patient was felt weak and was unable to get out of bed.  She was evaluated in the ER and hospitalized for pneumonia.  She received her second dose of vaccine on 3/9/2021.  On 3/30/2021, she felt the same way she had on 2/16/2021.  She went to the ER and was again hospitalized with pneumonia.  She also had severe gout flare up at the same time.  She continued to have respiratory problems, and in June of 2021 she developed the need for continuous supplemental oxygen.  Eventually, work-up for her shortness of breath and hypoxemia led to an echocardiogram which showed an EF of 29% which was a reduction from 50% in May 2019.  She was started on new heart failure medications at that time.  She was prescribed a Life Vest due to risk of arrhythmia due to markedly low EF.  She had a repeat echo after therapy for heart failure was initiated, and her EF had dropped to 23%.  She is now requiring BiPAP therapy due to new sleep apnea.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram
Clinical narrative: On 2/16/2021, one week after receiving dose 1, patient was felt weak and was unable to get out of bed.  She was evaluated in the ER and hospitalized for pneumonia.  She received her second dose of vaccine on 3/9/2021.  On 3/30/2021, she felt the same way she had on 2/16/2021.  She went to the ER and was again hospitalized with pneumonia.  She also had severe gout flare up at the same time.  She continued to have respiratory problems, and in June of 2021 she developed the need for continuous supplemental oxygen.  Eventually, work-up for her shortness of breath and hypoxemia led to an echocardiogram which showed an EF of 29% which was a reduction from 50% in May 2019.  She was started on new heart failure medications at that time.  She was prescribed a Life Vest due to risk of arrhythmia due to markedly low EF.  She had a repeat echo after therapy for heart failure was initiated, and her EF had dropped to 23%.  She is now requiring BiPAP therapy due to new sleep apnea.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gout, Hypoxia, Mobility decreased, Pneumonia, Positive airway pressure therapy
Clinical narrative: On 2/16/2021, one week after receiving dose 1, patient was felt weak and was unable to get out of bed.  She was evaluated in the ER and hospitalized for pneumonia.  She received her second dose of vaccine on 3/9/2021.  On 3/30/2021, she felt the same way she had on 2/16/2021.  She went to the ER and was again hospitalized with pneumonia.  She also had severe gout flare up at the same time.  She continued to have respiratory problems, and in June of 2021 she developed the need for continuous supplemental oxygen.  Eventually, work-up for her shortness of breath and hypoxemia led to an echocardiogram which showed an EF of 29% which was a reduction from 50% in May 2019.  She was started on new heart failure medications at that time.  She was prescribed a Life Vest due to risk of arrhythmia due to markedly low EF.  She had a repeat echo after therapy for heart failure was initiated, and her EF had dropped to 23%.  She is now requiring BiPAP therapy due to new sleep apnea.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory disorder, Sleep apnoea syndrome, Sleep study
Clinical narrative: On 2/16/2021, one week after receiving dose 1, patient was felt weak and was unable to get out of bed.  She was evaluated in the ER and hospitalized for pneumonia.  She received her second dose of vaccine on 3/9/2021.  On 3/30/2021, she felt the same way she had on 2/16/2021.  She went to the ER and was again hospitalized with pneumonia.  She also had severe gout flare up at the same time.  She continued to have respiratory problems, and in June of 2021 she developed the need for continuous supplemental oxygen.  Eventually, work-up for her shortness of breath and hypoxemia led to an echocardiogram which showed an EF of 29% which was a reduction from 50% in May 2019.  She was started on new heart failure medications at that time.  She was prescribed a Life Vest due to risk of arrhythmia due to markedly low EF.  She had a repeat echo after therapy for heart failure was initiated, and her EF had dropped to 23%.  She is now requiring BiPAP therapy due to new sleep apnea.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Mobility decreased
Clinical narrative: Received vaccination at 11:00a on 2/20.  Around 7:00p (same day) started having chills.  My whole body was shivering nonstop for about 3 hours.  Constant headache and weakness and slight temperature.  On 2/22/23, morning hours, I was dizzy and fainted but not unconscious.  Was able to get up after a few seconds.  Been in bed for 2 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Received vaccination at 11:00a on 2/20.  Around 7:00p (same day) started having chills.  My whole body was shivering nonstop for about 3 hours.  Constant headache and weakness and slight temperature.  On 2/22/23, morning hours, I was dizzy and fainted but not unconscious.  Was able to get up after a few seconds.  Been in bed for 2 days.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood creatine phosphokinase normal, Electrocardiogram normal, Tachycardia, Troponin
Clinical narrative: The first adverse event occurred in June and involved stabbing pains in my heart and the feeling of glass shards going through my heart. The same event happened several more times in 2021, off and on, and still in 2022 but not as strong. I also had a heart event in November 2021 in which it felt that my heart might give out and this lasted for about 15 minutes until it could calm down. Although I did have tachycardia, This was not SVT.  Additional events include daily unusual pains or aches in my heart, sometimes all day. I ran a half marathon 2 months after the vaccines, and yet began having novel heart issues a month after the run. I had a second heart episode November 2022 which lasted about 30 minutes. Treatments included lying on my back, drinking extra water (I was not dehydrated when stabbing pains or episodes occurred), eating extra green foods, avoiding solutes. Outcome includes recurring occasional stabbing pains and aches. Outcome of episodes includes resolved and heart beating normally after 15-30 minutes. I am still able to run and have run two 10ks since and a 5k. I am wary of doing another half marathon.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Brain scan normal, Cardiac stress test normal, Chest X-ray normal, Echocardiogram normal
Clinical narrative: I received my first dose of Pfizer-BioNTech on 1/21/21, after which I felt little effect besides mild dizziness and facial flush right after administration (which I've experienced after other vaccines, esp. HPV). However, after my 2nd dose on 2/11/21, I began to feel persistent fatigue, mild for the first week, then severe since. On 2/21/21, I developed a deep achiness in my arms and legs, which eventually became a more superficial tingling in my limbs and mouth that still persists to this day. I also became suddenly exercise intolerant, fatiguing quickly and experiencing severe PEM (post-exertional-malaise). I have always been a high-level athlete, and I was suddenly unable to even go for an easy jog on 2/22/21.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Impaired work ability, Laboratory test normal, Malaise
Clinical narrative: I received my first dose of Pfizer-BioNTech on 1/21/21, after which I felt little effect besides mild dizziness and facial flush right after administration (which I've experienced after other vaccines, esp. HPV). However, after my 2nd dose on 2/11/21, I began to feel persistent fatigue, mild for the first week, then severe since. On 2/21/21, I developed a deep achiness in my arms and legs, which eventually became a more superficial tingling in my limbs and mouth that still persists to this day. I also became suddenly exercise intolerant, fatiguing quickly and experiencing severe PEM (post-exertional-malaise). I have always been a high-level athlete, and I was suddenly unable to even go for an easy jog on 2/22/21.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia oral, Performance status decreased, SARS-CoV-2 test negative
Clinical narrative: I received my first dose of Pfizer-BioNTech on 1/21/21, after which I felt little effect besides mild dizziness and facial flush right after administration (which I've experienced after other vaccines, esp. HPV). However, after my 2nd dose on 2/11/21, I began to feel persistent fatigue, mild for the first week, then severe since. On 2/21/21, I developed a deep achiness in my arms and legs, which eventually became a more superficial tingling in my limbs and mouth that still persists to this day. I also became suddenly exercise intolerant, fatiguing quickly and experiencing severe PEM (post-exertional-malaise). I have always been a high-level athlete, and I was suddenly unable to even go for an easy jog on 2/22/21.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome, Sleep study abnormal, Syncope
Clinical narrative: I received my first dose of Pfizer-BioNTech on 1/21/21, after which I felt little effect besides mild dizziness and facial flush right after administration (which I've experienced after other vaccines, esp. HPV). However, after my 2nd dose on 2/11/21, I began to feel persistent fatigue, mild for the first week, then severe since. On 2/21/21, I developed a deep achiness in my arms and legs, which eventually became a more superficial tingling in my limbs and mouth that still persists to this day. I also became suddenly exercise intolerant, fatiguing quickly and experiencing severe PEM (post-exertional-malaise). I have always been a high-level athlete, and I was suddenly unable to even go for an easy jog on 2/22/21.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, No adverse event
Clinical narrative: At appt for bivalent Moderna booster 2/17/23, pt reports last COVID vaccine shot, Moderna booster, in first 5 minutes felt dizzy, felt like BP dropped and was about to faint. Was not mentioned at time of vaccine. Pt given Moderna bivalent booster 2/17/23 in supine position and observed for 30 min. No adverse reaction noted.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral, Postural orthostatic tachycardia syndrome, Tilt table test
Clinical narrative: Postural orthostatic tachycardia syndrome Neuropathy
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Child was given 0.5ml of the Moderna vaccine for 6 month to 5 years.  This was the first dose of a primary series.  The container that holds the vaccine in the fridge was mislabeled by staff and states to give 0.5 ml instead of 0.25ml.  This was immediately changed once this happened and we realized the error.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient was given  2 doses of Moderna Bivalent Once on 11/03/2022 and one on 02/21/2023.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: We were under the impression we were administering the Pfizer Bivalent COVID Booster but we discovered we actually administered the Pfizer Monovalent COVID Vaccine in error. Patient was made aware and given CDC guidance on how to proceed.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Pruritus, Skin swelling, Urticaria
Clinical narrative: I had full body hives. They were red, raised, itchy, and they come and go. When I went to the doctor, and they said they didn't know what cause them. They also started me on a couple medication and referred me to a dermatologist. I am still having problems with the hives.
Age: 1.75
Sex: M
Vaccine: UNK
Symptoms: Incorrect product formulation administered
Clinical narrative: PT given Bivalent Covid vaccine as first dose ,  Negative for any s/s PT waited 15 min evaluated by PCP sent home.  PTS 2nd Covid vaccine will be Monovalent.  PTS 3rd Covid Vaccine will be Bivalent
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: We were under the impression we were administering the Pfizer Bivalent COVID Booster but we discovered we actually administered the Pfizer Monovalent COVID Vaccine in error. Patient was made aware and given CDC guidance on how to proceed.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: We were under the impression we were administering the Pfizer Bivalent COVID Booster but we discovered we actually administered the Pfizer Monovalent COVID Vaccine in error. Patient was made aware and given CDC guidance on how to proceed.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Laboratory test
Clinical narrative: Patient stated 2 days after receiving vaccine he was having trouble breathing and was hospitalized and seen by pulmonologists there. Did not specify how long he was there. But since then he has had trouble breathing and was in a scooter with a oxygen mask on. Cannot move or walk without breathing issues.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Vaccination not given at our facility. Unable to determine manufacturer, lot, route, or site. Could be Havrix or Vaqta.  Pt presented to ED 06DEC22 @ 20:29 w/ mother for c/o rash to face and itching s/p HEP A vaccine at 1100. Diphenhydramine 25mg administered @ 20:39. Mother stated reaction started shortly after injection and pt had an axillary fever of 101.2F. Mother administered APAP 10mL and fever resolved. No prev rxns to other vaccines or medications. No breathing issues or tongue swelling. 1st HEP A vaccine 2017, no rxn. ED provider note indicates possible reaction to vaccine, will need to be cautious in the future with prolonged observation after injections. Mom aware. Pt discharged w/ diphenhydramine 12.5mg/5mL take 10mL PO TID PRN itching and prednisolone 15mg/5mL take 10mL PO daily x3 days.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: Unknown specific influenza vaccine information. Not administered at our site.   Pt presented to ED 29DEC22 @ 15:14 w/ mother for facial swelling post influenza vaccine administration. Pt received vaccine at approx 12-1230 and shortly after developed facial swelling to bilateral cheeks and eyelids. Diphenhydramine 15mg administered in ED @ 16:38. Pt discharged w/ diphenhydramine, cetirizine, and EpiPen. Parent educated on EpiPen use and was provided close follow-up instructions and strict return precautions.
Age: 24.0
Sex: M
Vaccine: JEV1, TYP, YF
Symptoms: Dyspnoea, Nausea, Swollen tongue
Clinical narrative: Japanese enceph vacc SA14-14-2, inactivated Yellow Fever unclear in our records if YF-Vax vs. Stamaril. Manufacturer is Sanofi pasteur.  Pt received Japanese Encephalitis, typhoid, and yellow fever vaccines during mass vaccination on 13DEC22 @ approx. 1354. Approx 45 minutes later, pt noticed nausea w/o vomiting, sensation of tongue swelling, and SOB. Pt took OTC Benadryl shortly thereafter. Pt presented to ED 13DEC22 @ 1649 with SOB. Administered STAT diphenhydramine 50mg @ 1700. Per ED provider note, patient may have had a mild allergic reaction to 1 of the 3 vaccines he received at the mass vaccination event this afternoon. ADR investigation ? unpreventable ADR, Level 3 moderate requiring treatment. Pt treated w/ diphenhydramine 50mg in ED and discharged home with rest, fluids, repeated diphenhydramine if needed, w/ ED return instructions should he develop delayed symptoms of anaphylaxis or serum sickness. No since ED visits. PCM visit 22DEC22 for flight physical, however did not mention reaction. Notified PCM and added to allergies.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: patient received dose of vaccine that was past beyond use date; manufacturer confirmed no need to revaccinate due to determination that vaccine was still active at time of administration
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: patient received dose of vaccine that was past beyond use date; manufacturer confirmed no need to revaccinate due to determination that vaccine was still active at time of administration
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Inadvertently administered additional Bivalent Booster after 2 months of Bivalent booster
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: patient received dose of vaccine that was past beyond use date; manufacturer confirmed no need to revaccinate due to determination that vaccine was still active at time of administration
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: patient received dose of vaccine that was past beyond use date; manufacturer confirmed no need to revaccinate due to determination that vaccine was still active at time of administration
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Blindness unilateral, Magnetic resonance imaging, Optic neuritis, X-ray
Clinical narrative: Optic Neuritis in left eye, vision loss in left eye
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Lymphadenopathy, Lymphoedema, Pruritus
Clinical narrative: None stated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory disorder, Weight decreased
Clinical narrative: None stated.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Photopsia, Vision blurred, Vitreous floaters
Clinical narrative: increased floaters in eyes, extreme blurriness in both eyes and peripheral vision light flashes in both eyes.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Pain
Clinical narrative: The day after the vaccine, I started to feel achy, cold, and tired.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Blood test, Computerised tomogram abdomen abnormal, Diverticulitis intestinal perforated
Clinical narrative: day after pt got Moderna bivalent booster , she had severd abdominal pain, went to ER and CT showed diverticulitis with microperforation
Age: 12.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Vaccination error, Wrong product administered
Clinical narrative: Oversight looking at system and gave second dose of meningococcal conjug. It should of been HPV. Caregiver informed, vaers and occurrence report completed.
Age: 12.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: Oversight looking at system and gave second dose of meningococcal conjug. It should of been HPV. Caregiver informed, vaers and occurrence report completed.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pyrexia, Swelling
Clinical narrative: Pt started feeling nauseated several hours after administration. The morning after ran fever of 102. Small amount of localized swelling noted at that time. Treated fever with OTC meds. Pt without fever or symptom within 2 days.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Been having looser stools for 2 days. Vomiting for 3 days.
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure fluctuation, Heart rate abnormal, Laboratory test, Postural orthostatic tachycardia syndrome
Clinical narrative: After getting the new Moderna Covid bivalent booster, I had significant heart rate/blood pressure fluctuations requiring an emergency room visit and several medical tests. I have been diagnosed w/POTs like symptoms and now have to take propranolol twice daily.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Exposure during pregnancy, Premature labour, SARS-CoV-2 test positive
Clinical narrative: 09/05/22 presents to Triage for "contractions" "38w0d". PMHx of "Hypertension" "history of a prior preterm delivery at 32w after going into pre-term labor"
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Abnormal loss of weight, Bladder diverticulum, COVID-19
Clinical narrative: Diagnosed with exocrine pancreatic insufficiency; acute pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Nurse) The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PANCREATITIS ACUTE (medically significant) with onset Dec2021, outcome "unknown", described as "acute pancreatitis"; PANCREATIC FAILURE (medically significant), outcome "unknown", described as "Diagnosed with exocrine pancreatic insufficiency". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Jan2022) Positive, notes: Second time; Weight decreased: (unspecified date) 30lbs.  Clinical course: Patient had episode of acute pancreatitis Dec2021. Patient tested COVID-19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency (EPI) after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Patient had no preexisting medical history documented by regular pcp visits.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events acute pancreatitis, Pancreatic failure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram abdomen abnormal, Diarrhoea, Faecal elastase test, Hepatobiliary scan
Clinical narrative: Diagnosed with exocrine pancreatic insufficiency; acute pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Nurse) The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PANCREATITIS ACUTE (medically significant) with onset Dec2021, outcome "unknown", described as "acute pancreatitis"; PANCREATIC FAILURE (medically significant), outcome "unknown", described as "Diagnosed with exocrine pancreatic insufficiency". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Jan2022) Positive, notes: Second time; Weight decreased: (unspecified date) 30lbs.  Clinical course: Patient had episode of acute pancreatitis Dec2021. Patient tested COVID-19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency (EPI) after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Patient had no preexisting medical history documented by regular pcp visits.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events acute pancreatitis, Pancreatic failure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lipase increased, Nausea, Pancreatic failure, Pancreatitis acute, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with exocrine pancreatic insufficiency; acute pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Nurse) The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PANCREATITIS ACUTE (medically significant) with onset Dec2021, outcome "unknown", described as "acute pancreatitis"; PANCREATIC FAILURE (medically significant), outcome "unknown", described as "Diagnosed with exocrine pancreatic insufficiency". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Jan2022) Positive, notes: Second time; Weight decreased: (unspecified date) 30lbs.  Clinical course: Patient had episode of acute pancreatitis Dec2021. Patient tested COVID-19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency (EPI) after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Patient had no preexisting medical history documented by regular pcp visits.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events acute pancreatitis, Pancreatic failure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound abdomen normal, Weight decreased
Clinical narrative: Diagnosed with exocrine pancreatic insufficiency; acute pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Nurse) The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PANCREATITIS ACUTE (medically significant) with onset Dec2021, outcome "unknown", described as "acute pancreatitis"; PANCREATIC FAILURE (medically significant), outcome "unknown", described as "Diagnosed with exocrine pancreatic insufficiency". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Jan2022) Positive, notes: Second time; Weight decreased: (unspecified date) 30lbs.  Clinical course: Patient had episode of acute pancreatitis Dec2021. Patient tested COVID-19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency (EPI) after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Patient had no preexisting medical history documented by regular pcp visits.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events acute pancreatitis, Pancreatic failure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pancreatic failure, Pancreatitis acute, SARS-CoV-2 test, Weight decreased
Clinical narrative: Diagnosed with exocrine pancreatic insufficiency; acute pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Nurse) The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PANCREATITIS ACUTE (medically significant) with onset Dec2021, outcome "unknown", described as "acute pancreatitis"; PANCREATIC FAILURE (medically significant), outcome "unknown", described as "Diagnosed with exocrine pancreatic insufficiency". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Jan2022) Positive, notes: Second time; Weight decreased: (unspecified date) 30lbs.  Clinical course: Patient had episode of acute pancreatitis Dec2021. Patient tested COVID-19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency (EPI) after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Patient had no preexisting medical history documented by regular pcp visits.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events acute pancreatitis, Pancreatic failure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.