chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmic migraine, Pain, Photopsia, Pyrexia
Clinical narrative: General soreness and 102-degree fever the following day.  The unexpected event following the injection occurred on 10/25/23 following the 10/22/23 injection.  This was a 10-15-minute manifestation of kaleidoscopic effect and lights at the right periphery of my vision in my right eye, which was diagnosed as an ocular migraine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Gastrointestinal disorder, Gastrointestinal pain, Injection site erythema
Clinical narrative: Shortness of breath and GI pain 15 minutes after receiving vaccine.  Given Loratadine 10mg at office.  Still experiencing GI symptoms. Developed half dollar sized raised and painful red rash and muscle pain at injection site 24 hours post injection.  Still experiencing. Developed diarrhea 24 hours post injection.  Taking Pepto Bismol as package directs to help mitigate.  Still experiencing.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Shortness of breath and GI pain 15 minutes after receiving vaccine.  Given Loratadine 10mg at office.  Still experiencing GI symptoms. Developed half dollar sized raised and painful red rash and muscle pain at injection site 24 hours post injection.  Still experiencing. Developed diarrhea 24 hours post injection.  Taking Pepto Bismol as package directs to help mitigate.  Still experiencing.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; improperly stored vaccine; This spontaneous report was received from a healthcare worker and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 16-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #x010531, expiration date: 11-APR-2025, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) which temperature showed -14 C for 47 minutes. There's no previous temperature excursion/ Previous temperature excursion showed -9.7 C for 40 minutes (product storage error). No additional adverse events (AEs) were reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product use in unapproved indication
Clinical narrative: to prevent throat and neck cancer; No further AE information; This spontaneous report was received from a pharmacist vis company representative and referred to a male patient of unknown age. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date, This patient was requesting the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for throat and neck cancer (strength, lot #, expiry date, and route of administration were not provided) as it was recommended he receive it by his doctor since he was at high risk for smoke inhalation based on his occupation. It was unable to confirm with the pharmacist if the vaccine was given to the patient., and it could not be confirmed if the patient did or did not receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product use in unapproved indication). No further adverse event (AE) information.
Sex: U
Vaccine: COVID19
Symptoms: Dry skin, Pruritus
Clinical narrative: itching of skin; dry skin; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching of skin) and DRY SKIN (dry skin) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PRURITUS (itching of skin) and DRY SKIN (dry skin). At the time of the report, PRURITUS (itching of skin) and DRY SKIN (dry skin) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (itching of skin) and DRY SKIN (dry skin) to be related.    Concomitant medication was not reported.  It was reported that the patient had discovered a link between the vaccines and skin problems in 2021. Within 4 days caller has itching of skin which lasted for 4 months. The patient thought it was just dry skin and was sure it was from the shot. The patient took Moderna vaccine in October of 2022 and did not have any problems with that. Now it is 2023, they were worried what would happen if they get another vaccine from Moderna.  Treatment medication was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: Caller states that she was talking to one of her friends regarding her reaction and he told her that when he googled, he saw that women were experiencing this reaction more than others; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Caller states that she was talking to one of her friends regarding her reaction and he told her that when he googled, he saw that women were experiencing this reaction more than others) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller states that she was talking to one of her friends regarding her reaction and he told her that when he googled, he saw that women were experiencing this reaction more than others). At the time of the report, IMMUNISATION REACTION (Caller states that she was talking to one of her friends regarding her reaction and he told her that when he googled, he saw that women were experiencing this reaction more than others) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Nausea, Pain in extremity, Pharyngeal swelling
Clinical narrative: her throat is swollen; her arm is a little sore; She has Watery Diarrhea/ really bad diarrhea; a little bit of nausea; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (her throat is swollen), PAIN IN EXTREMITY (her arm is a little sore), DIARRHOEA (She has Watery Diarrhea/ really bad diarrhea) and NAUSEA (a little bit of nausea) in a 48-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058628) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 31-Oct-2023, the patient experienced PHARYNGEAL SWELLING (her throat is swollen), PAIN IN EXTREMITY (her arm is a little sore), DIARRHOEA (She has Watery Diarrhea/ really bad diarrhea) and NAUSEA (a little bit of nausea). At the time of the report, PHARYNGEAL SWELLING (her throat is swollen) and PAIN IN EXTREMITY (her arm is a little sore) outcome was unknown and DIARRHOEA (She has Watery Diarrhea/ really bad diarrhea) and NAUSEA (a little bit of nausea) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No relevant concomitant medications were reported.  It was reported that patient's throat was swollen but she could still swallow food. She does not have sore throat. No treatment medication reported.   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Chest X-ray normal, Dyspnoea, Headache, Injection site urticaria
Clinical narrative: Next day welt at injection site, stiff arm, full body joint pain, painful breathing / shortness of breath, ringing in ears for hours, and headache. Recommended by nurse line to go to ER. Joint pain and ringing in ears continue on 2 NOV 2023 after discharge.  Had previous shot a year ago with only injection site pain, second shot given 31 October lead to above symptoms
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Musculoskeletal stiffness, Painful respiration, Tinnitus, White blood cell count increased
Clinical narrative: Next day welt at injection site, stiff arm, full body joint pain, painful breathing / shortness of breath, ringing in ears for hours, and headache. Recommended by nurse line to go to ER. Joint pain and ringing in ears continue on 2 NOV 2023 after discharge.  Had previous shot a year ago with only injection site pain, second shot given 31 October lead to above symptoms
Sex: U
Vaccine: COVID19, FLUC4
Symptoms: Fatigue, Injection site mass, Injection site pain, Myalgia, Nasopharyngitis
Clinical narrative: Muscles ache at multiple areas of body, similar to having a cold. The injection area has a big lump under the skin and it?s hurt when touched. Also I feel fatigue and tired and it?s the fourth day after the vaccine. Also I feel thirsty and drank a lot of water.
Sex: U
Vaccine: COVID19, FLUC4
Symptoms: Thirst
Clinical narrative: Muscles ache at multiple areas of body, similar to having a cold. The injection area has a big lump under the skin and it?s hurt when touched. Also I feel fatigue and tired and it?s the fourth day after the vaccine. Also I feel thirsty and drank a lot of water.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Angiocardiogram, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax
Clinical narrative: Acute inflammatory demyelinating polyneuropathy or Guillain-Barre causing subsequent respiratory failure and aspiration pneumonia Leading to long hospitalization ICU stay intubation for 5 days 5 doses of IVIG and 5 episodes of plasmapheresis
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Echocardiogram, Electromyogram, Endotracheal intubation, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Acute inflammatory demyelinating polyneuropathy or Guillain-Barre causing subsequent respiratory failure and aspiration pneumonia Leading to long hospitalization ICU stay intubation for 5 days 5 doses of IVIG and 5 episodes of plasmapheresis
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Intensive care, Magnetic resonance imaging spinal, Plasmapheresis, Pneumonia aspiration, Respiratory failure
Clinical narrative: Acute inflammatory demyelinating polyneuropathy or Guillain-Barre causing subsequent respiratory failure and aspiration pneumonia Leading to long hospitalization ICU stay intubation for 5 days 5 doses of IVIG and 5 episodes of plasmapheresis
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: night of vaccine had joint pain in both feet, both ankles, back pain, hand pain ongoing now for 3 weeks
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness/swelling/pain to site
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 10/30/2023 - observed, red area 1" in diameter tender 11/2/2023 - observed, red,  1 1/2 area, red hot, puffy, tender, itchy, local reaction (R) deltoid.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Local reaction, Tenderness
Clinical narrative: 10/30/2023 - observed, red area 1" in diameter tender 11/2/2023 - observed, red,  1 1/2 area, red hot, puffy, tender, itchy, local reaction (R) deltoid.
Age: 67.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Atrial fibrillation, Cerebral infarction, Cerebrovascular accident, Dysarthria, Facial paralysis
Clinical narrative: Reported Symptoms: 10042244:STROKE; Narrative: 10/03/2023- Admitted to Medical Center with A.Fib with RVR and Right facial drooping and dysarthria. MR brain without contrast showed focus of acute infarct involving the left frontal lobe Other Relevant HX: Other:
Age: 67.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: Reported Symptoms: 10042244:STROKE; Narrative: 10/03/2023- Admitted to Medical Center with A.Fib with RVR and Right facial drooping and dysarthria. MR brain without contrast showed focus of acute infarct involving the left frontal lobe Other Relevant HX: Other:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy
Clinical narrative: 10025197:LYMPHADENOPATHY; Narrative:  Other Relevant HX: Other; Lymphadenopathy
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Hallucination, Mental status changes
Clinical narrative: Reported Symptoms: 10019077:HALLUCINATIONS; 10048294:MENTAL STATUS CHANGE; Narrative:  Other Relevant Hx:  Other: MENTAL STATUS CHANGES
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4, HEP, IPV, MMRV
Symptoms: Chest pain, Electrocardiogram, Headache, Laboratory test, Pericarditis
Clinical narrative: Sudden onset chest pain and headache, seen in ER, dx with pericarditis.  Currently seeing cardiology.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4, HEP, IPV, MMRV
Symptoms: Troponin
Clinical narrative: Sudden onset chest pain and headache, seen in ER, dx with pericarditis.  Currently seeing cardiology.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error, Underdose
Clinical narrative: patient only received half of the vaccine. Was not mixed properly.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Abdominal pain upper, Dermatitis diaper, Diarrhoea, Hypersomnia, Infant irritability
Clinical narrative: Slept a lot after administration, belly pain with being inconsolable, diarrhea, diaper rash.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Decreased appetite, Feeling abnormal, Feeling of body temperature change, Headache
Clinical narrative: She got her vaccine, had the normal reactions, sinus and things right away.  She had a headache and thought that was unusual as it is rare for her to get a headache.  On Sunday 10/29/23 it started all up again, has had a fever, as well as really bad headache since Sunday.  She is hot/cold because she is running a temperature, sweaty/clamy.  She has no sinus issues, no congestion, none of that really, she just feels awful.  She has loss of appetite and has not eaten in the last few days or so.  She has been taking vitamin D3, as well as Oscillocoecinum a homeopathic remedy, which she just started taking it on Tuesday and she does not see any help from it yet.  She has a Telehealth APT tomorrow.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: She got her vaccine, had the normal reactions, sinus and things right away.  She had a headache and thought that was unusual as it is rare for her to get a headache.  On Sunday 10/29/23 it started all up again, has had a fever, as well as really bad headache since Sunday.  She is hot/cold because she is running a temperature, sweaty/clamy.  She has no sinus issues, no congestion, none of that really, she just feels awful.  She has loss of appetite and has not eaten in the last few days or so.  She has been taking vitamin D3, as well as Oscillocoecinum a homeopathic remedy, which she just started taking it on Tuesday and she does not see any help from it yet.  She has a Telehealth APT tomorrow.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Aphonia
Clinical narrative: On November 1st, I lost my voice. I am not talking like my regular self. My doctor says that she think it's due to the RSV vaccine. She said when you get the RSV vaccine, it's a live virus they put in you. I dont think I will ever get it again.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Muscle contractions involuntary, Muscle spasms
Clinical narrative: Influenza seasonal vaccine. Unknown manufacturer. Involuntary muscle spasms and fasciculations throughout body.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Dyskinesia, Face injury, Seizure
Clinical narrative: I believe that I had slight seizure activity. I was aware the entire time and I feel it was brief, less than a minute in total. My right arm started flailing and I was unable to control it. I hit my face hard enough to knock my eyeglasses off. I was holding onto the doorframe with my left hand so was able to stay upright the entire time. No further events since.
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE REACTIONS. POLIO WAS NOT NEEDED FOR PATIENT. EXTRA DOSE WAS GIVEN.
Age: 0.83
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Granuloma
Clinical narrative: Presumed granuloma in left thigh, developed within 24 hours of administration, still present 1 month after administration
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Chest pain, Echocardiogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: As I was leaving the doctor?s office  developed chests pains on the left side.  Chest pains continued for next 3 hours, and after consulting doctor?s office I was advised to go to ER.  I was at the ER for over 6 hours and cardiac testing ruled out a myocardial event.  In fact, cardiac testing has been normal , and I had a follow up echocardiogram on Monday 10/30/23.  I did continue to have chest pains the remainder of the day on 10/17/23 even after discharge from ER.  Chest pains were more intense with movement. I received a toradol shot at ER about 9:00-9:30pm.  When I got home I continued to have chest pains and went to bed around 11:30 pm with continued pain.  When I woke up the next morning my chest pains were gone.  I did not feel well on 10/18/23 but mostly I was tired from the ER ordeal.  I was back to normal by 10/19/23.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Pain
Clinical narrative: As I was leaving the doctor?s office  developed chests pains on the left side.  Chest pains continued for next 3 hours, and after consulting doctor?s office I was advised to go to ER.  I was at the ER for over 6 hours and cardiac testing ruled out a myocardial event.  In fact, cardiac testing has been normal , and I had a follow up echocardiogram on Monday 10/30/23.  I did continue to have chest pains the remainder of the day on 10/17/23 even after discharge from ER.  Chest pains were more intense with movement. I received a toradol shot at ER about 9:00-9:30pm.  When I got home I continued to have chest pains and went to bed around 11:30 pm with continued pain.  When I woke up the next morning my chest pains were gone.  I did not feel well on 10/18/23 but mostly I was tired from the ER ordeal.  I was back to normal by 10/19/23.
Age: 44.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: limited range of motion in the left shoulder painful to move and tender and sore to the touch patient has tried ibuprofen over the counter with no relief and gentle hand message
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Off label use, Wrong product administered
Clinical narrative: was given pediarix off label vs giving TDaP, and IPV
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE REACTIONS. POLIO WAS GIVEN TOO SOON
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus
Clinical narrative: I've been using a continuous glucose monitor for years, and my blood sugars are in good control.  Starting the day of the vaccination and continuing for about two more days, my blood sugars were abnormally high (above 200 mg/dl) much of the time, and it was difficult to keep them in the normal range.  I've not experienced this reaction to any vaccination in the past.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Herpes zoster, Pain, Pain in extremity
Clinical narrative: 10/21/23 typical vaccine symptoms (arm pain, minor aches and pains, medium headache 10/23/23 Itching on right arm, severe headache, pain in arm increased, pain started in right shoulder and went down to fingertips, 10/24/23 Went to Emergency Room (Medical Center) due to extreme pain right  shoulder                          and three pock marks on right side of shoulder. also experiencing headaches and itching in the same area. Diagnosis at ER was Shingles.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scar, X-ray
Clinical narrative: 10/21/23 typical vaccine symptoms (arm pain, minor aches and pains, medium headache 10/23/23 Itching on right arm, severe headache, pain in arm increased, pain started in right shoulder and went down to fingertips, 10/24/23 Went to Emergency Room (Medical Center) due to extreme pain right  shoulder                          and three pock marks on right side of shoulder. also experiencing headaches and itching in the same area. Diagnosis at ER was Shingles.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Bursitis
Clinical narrative: Pt presenting today for evaluation of Left shoulder pain after receiving last Hep B vax.  States her vaccine was given higher than usual and hurt really bad going in.  In so much pain, she is unable to lay on her left side.  This has never happened to her before.  Diagnosed with shoulder bursitis. Recommended 400-600mg ibuprofen every 6 hours for 2 weeks, diclofenac gel and ice
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: on fifth day post injection; right upper arm injection site 5-6 cm diameter area of redness, swelling, warmth and itching. sixth day post injection; site is 5-6 cm diameter, more red, still warm and slightly swollen and itchy. fatigue and slight headache felt
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth
Clinical narrative: on fifth day post injection; right upper arm injection site 5-6 cm diameter area of redness, swelling, warmth and itching. sixth day post injection; site is 5-6 cm diameter, more red, still warm and slightly swollen and itchy. fatigue and slight headache felt
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Pyrexia
Clinical narrative: Patient was quickly tired after the shot. Went to bed without any supportive treatment at home and woke up with a 104.8 fever that took 30min to start to decrease with 160mg of feverall.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Eye pain, Feeling abnormal
Clinical narrative: SPIKEVAX 12+ (COVID) 23-24 PFS      Severe incapacitating vertigo, vomiting, loss of balance, headache, low grade fever, chills, muscle pain, eye pain Prescribed 25 mg Meclizine 3x daily, 4 mg  Ondansetron every 6 hours Also took acetaminophen every 6 hours Severe vertigo and vomiting lasted about 4 hours until meds, reoccurred when time to take meds again, lingering dizziness, nausea, feeling  'off' 3 days after vaccine
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vertigo
Clinical narrative: SPIKEVAX 12+ (COVID) 23-24 PFS      Severe incapacitating vertigo, vomiting, loss of balance, headache, low grade fever, chills, muscle pain, eye pain Prescribed 25 mg Meclizine 3x daily, 4 mg  Ondansetron every 6 hours Also took acetaminophen every 6 hours Severe vertigo and vomiting lasted about 4 hours until meds, reoccurred when time to take meds again, lingering dizziness, nausea, feeling  'off' 3 days after vaccine
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SPIKEVAX 12+ (COVID) 23-24 PFS      Severe incapacitating vertigo, vomiting, loss of balance, headache, low grade fever, chills, muscle pain, eye pain Prescribed 25 mg Meclizine 3x daily, 4 mg  Ondansetron every 6 hours Also took acetaminophen every 6 hours Severe vertigo and vomiting lasted about 4 hours until meds, reoccurred when time to take meds again, lingering dizziness, nausea, feeling  'off' 3 days after vaccine
Age: 41.0
Sex: M
Vaccine: FLUR4, TDAP
Symptoms: Presyncope, Syncope
Clinical narrative: Patient after receiving Flublok and Adacel, fainted...appeared to have a vagal reaction after around 5 minutes.  EMT's were called came and monitored patient until he had a stable blood pressure and released him under his wife's care who was with him.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak started 3 days after receiving Flu Vaccine. This is the first time I have had Shingles. I researched and found studies that the Flu Vaccine can in fact cause a shingles outbreak in some people, usually within 3-15 days post Flu Vaccine administration.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Decreased appetite, Infant irritability, Pyrexia
Clinical narrative: Decreased Appetite, fever, Fussy.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received the Abrysvo RSV vaccine 09/13/2023 and the Arexvy 11/02/2023
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: On 9/11/23 The EUA for covid-19 vaccine bivalent, mRNA LNP-S(12 yrs up)(PF) 30 mcg/0.3 mL Suspension [ERX 242317] (NDC 59267-0304-1) expired. An administration for covid-19 vaccine bivalent, mRNA LNP-S(12 yrs up)(PF) (PFIZER-BIONTECH) 30 mcg/0.3 mL injection (EMERGENCY USE AUTHORIZATION) 30 mcg Order ID 1210273174 was found on 9/21/23. This is after the EUA had expired.  No adverse effects of the administration are known at this time.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Palpitations, Sleep disorder
Clinical narrative: Awoke that night to a pounding, racing heart around 100 beats per minute that would not stop after 30 minutes of waiting. Rose from bed and felt faint, like I would pass out, so I lay back down. Considered calling an ambulance, but the faintness and racing heart improved after another 30 minutes and resolved by the next morning.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Electric shock sensation, Feeling cold, Hypoaesthesia, Injection site mass
Clinical narrative: I received the first dose of the Pfizer covid-19 vaccine on Friday night at 8:30 pm. At around 10 pm I felt like my body was going into shock: waves of numbness and cold washing over me repeatedly, and felt like my body and heart were relaxing too much, and I would go into shock at any moment. I was very close to asking my husband to take me to the hospital. After about 30 minutes it subsided however around midnight I was feeling what I can only describe as heart zings where I felt like the electrical system around my heart was giving me electric zaps throughout my body. I did not have any headache or nausea, but just continues to feel like my body could go into shock or stop functioning at any moment. It did not settle down enough to rest until 2 am.  I have never had this type of reaction to a vaccine since I was 2 months old, not even when given multiple shots at once during basic training.   When I contacted my provider the following morning I was told that this reaction could be normal. As I stated above I have never had this type of reaction before. This was far from normal.  I was still feeling weak and drained  from the shock to my system and my body felt off, but otherwise the shocks had subsided. I did have swelling along my left arm, and an acne bump appeared near the immunization site.   My provider said they would not be filing an adverse reaction report for me, even though I had provided all of the information regarding my extreme reaction to the vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: I received the first dose of the Pfizer covid-19 vaccine on Friday night at 8:30 pm. At around 10 pm I felt like my body was going into shock: waves of numbness and cold washing over me repeatedly, and felt like my body and heart were relaxing too much, and I would go into shock at any moment. I was very close to asking my husband to take me to the hospital. After about 30 minutes it subsided however around midnight I was feeling what I can only describe as heart zings where I felt like the electrical system around my heart was giving me electric zaps throughout my body. I did not have any headache or nausea, but just continues to feel like my body could go into shock or stop functioning at any moment. It did not settle down enough to rest until 2 am.  I have never had this type of reaction to a vaccine since I was 2 months old, not even when given multiple shots at once during basic training.   When I contacted my provider the following morning I was told that this reaction could be normal. As I stated above I have never had this type of reaction before. This was far from normal.  I was still feeling weak and drained  from the shock to my system and my body felt off, but otherwise the shocks had subsided. I did have swelling along my left arm, and an acne bump appeared near the immunization site.   My provider said they would not be filing an adverse reaction report for me, even though I had provided all of the information regarding my extreme reaction to the vaccine.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Headache, Lymphadenopathy, Pyrexia, Skin discolouration
Clinical narrative: one day after receiving the updated COVID booster (SpikeVax, aka Moderna), I experienced fever, change in color on face (red/purplish color) swelling of the face, bad headache, sleepiness, as well as lymph node swelling.  While I had lymph node swelling from ALL Moderna COVID shots (this was my 5th or 6th, I've lost count), I've never had the other reactions, so think this should be reported (fever, swelling/change of color in face).  Took lots of Benadryl for my face, and it is much better today (02Nov20230
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Somnolence, Swelling face
Clinical narrative: one day after receiving the updated COVID booster (SpikeVax, aka Moderna), I experienced fever, change in color on face (red/purplish color) swelling of the face, bad headache, sleepiness, as well as lymph node swelling.  While I had lymph node swelling from ALL Moderna COVID shots (this was my 5th or 6th, I've lost count), I've never had the other reactions, so think this should be reported (fever, swelling/change of color in face).  Took lots of Benadryl for my face, and it is much better today (02Nov20230
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC15, RV5
Symptoms: Alopecia, Alopecia areata, Haemangioma of skin
Clinical narrative: Patient has a small capillary hemangioma in hair line at nape of neck just R of midline. 1 day after her vaccine family noted hair loss overlying this hemangioma. They were seen by myself on 11/2 and she did have a smooth area of hair loss overlying her hemangioma with ongoing hair loss noted circumferentially around this area consistent with alopecia areata. She has been referred to dermatology for additional evaluation
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Death
Clinical narrative: I RECEIVED A CALL FROM ASSISTED LIVING FACILITY DIRECTOR OF NURSING THIS MORNING THAT DR. PASSED AWAY LAST NIGHT AROUND 8PM.  SHE WANTED TO LET US KNOW SINCE HE HAD HIS VACCINE FOR RSV YESTERDAY  BETWEEN 3 AND 330 PM.  NO ONE KNOWS IF THAT WAS INVOLVED, BUT WE WANTED TO REPORT .
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Injection site pain, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: She got her vaccine, she felt very good, happy it was over.  Later on in the day the injection area started to hurt, which she expected.  On that day it a busy day and then around 6-7:00 PM her throat started burning.  It's been a long time she had a sore throat and as the hours progressed she could feel it getting worse.  Once her company left by 9:00 PM her grandson came to visit and then he left and as the night went on she felt worse and the throat was really hurting.  Her nose started running and went to bed around 12:00.  Yesterday from 10:00 AM to last night her nose never stopped running.  She went through 4 boxes of tissues, clear mucus.  Then she just started breathing in, taking deep breaths, and had taken 2 tablespoons of Dayquill and had no fever, 97.8 last night but she never actually has had a fever.  She has had a lot of sneezing and coughing intermittently, not like she would get a constant cough, just once in a while.  When she laid down last night and felt that it would go away.  She has been gargline with Listerine with the alcohol in it.  She still has a runny nose today, but not as bad as yesterday.  She is going to do a COVID test to make sure that it was not that.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: She got her vaccine, she felt very good, happy it was over.  Later on in the day the injection area started to hurt, which she expected.  On that day it a busy day and then around 6-7:00 PM her throat started burning.  It's been a long time she had a sore throat and as the hours progressed she could feel it getting worse.  Once her company left by 9:00 PM her grandson came to visit and then he left and as the night went on she felt worse and the throat was really hurting.  Her nose started running and went to bed around 12:00.  Yesterday from 10:00 AM to last night her nose never stopped running.  She went through 4 boxes of tissues, clear mucus.  Then she just started breathing in, taking deep breaths, and had taken 2 tablespoons of Dayquill and had no fever, 97.8 last night but she never actually has had a fever.  She has had a lot of sneezing and coughing intermittently, not like she would get a constant cough, just once in a while.  When she laid down last night and felt that it would go away.  She has been gargline with Listerine with the alcohol in it.  She still has a runny nose today, but not as bad as yesterday.  She is going to do a COVID test to make sure that it was not that.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer COVID Vaccine ages 6mo-4y diluted on 10/31/23 at 506pm was given on 11/1/23 at 806am. This is beyond the MIFU time of 12h post-dilution. Made call to Pfizer and spoke to a pharmacist who said extended stability data post-dilution at 35-86F showed no impact for up to 24h storage in vials and in syringes. Dilution information not written on internal documentation sheet. Administrating MA did not see time written on labeled syringe.
Age: 2.25
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 2 yo child received Covid vaccine for 12 yrs and up by mistake
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of Havrix given to pediatric patient inadvertently.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired vaccine administration
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Lip swelling, Pruritus, Skin warm
Clinical narrative: I started having a reaction right away, but didn't think anything of it. I was itchy sporadically. I started getting really red, hot, and very itchy. I had bright red rash on my face, neck, and chest.  I immediately took a Zyrtec and called my MD. The rash and redness subsided a little after taking the Zyrtec. The itchiness was less, however, still itchy. I started to have diarrhea. On my way home, my bottom lip was swelling. I spoke with my PCP.  He told me to take 50 mg additional of Benedryl when i got home and to take Pepcid for my stomach. I was much better the next day.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient reports itchy rash on abdomen that started after vaccination
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Dose given was higher than recommended dose. Patient received 12+ dose of COVID vaccine.
Age: 91.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Cough, Fatigue, Nausea, Respiratory tract congestion
Clinical narrative: High dose IM 3V. Symptoms are stomach pain and nausea, tiredness. Going on almost 5 days on and off. Some coughing and congestion.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Loss of personal independence in daily activities, Myalgia, Sleep disorder
Clinical narrative: Patient reported severe joint/muscle pain and headache that prevented her from sleeping or even being able to do normal daily activities. Patient is OTC pain medication to treat but its effectiveness has been limited.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arrhythmia, Cardiac flutter, Dizziness, Palpitations
Clinical narrative: Heart palpitations, arrhythmias event during sleep  Dizziness from fluttering feeling
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized swelling, redness, tenderness around injection site.
Age: 32.0
Sex: M
Vaccine: PNC20
Symptoms: Fatigue, Injection site pain
Clinical narrative: Minor AE's: Pain at the injection site and Fatigue. I took Tylenol for the pain.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever & chills 12 hours after shot - took Tylenol to relieve fever. Tiredness the next day.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Ear discomfort, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: 11/01/2023 -   0600-woke with symptoms of bumps on neck 0900- rash began to itch. Rash was located on face, neck and hands. Raised red rash irregular shaped clustered areas. 1200- took claritin 10mg 1300- rash spread to arms/forearms and 3-4 spots on lower back 1400-benadryl 50mg  11/02/2023 rash became worse. Same areas darker red at this time. Just deeper red color. Arm area more profound rash. Now have a burning sensation in ears. 1100- Patient went to PCP. He prescribed Solumedrol 40mg IM, and prescribed Medrol dose pack.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was ordered high dose Flu vaccine. Patient was given standard dose flu vaccine. They were eligible for high dose. This happened here.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Pyrexia, Vomiting, Wrong product administered
Clinical narrative: Patient was erroneously given additional dose of the HIB vaccination.  CMT gave patient the Vaxelis which includes Hib with an additional Hib vaccination.  CMT charted in the chart that the Pediarix which includes DTaP, hep B, IPV was given when in fact the Vaxelis was given.  Immunization was verified with another CMT. Patient will be seen today in clinic due to fever and vomiting.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anal incontinence, Asthenia, Autoimmune encephalopathy, Blood gases, Cognitive disorder
Clinical narrative: Autoimmune Encephalopahy - Weakness, confusion, delirium, tremors, monoclonal muscle spasms upper and lower extremities, inability to sleep, loss of coordination, loss of cognitive function, inability to control bowel or badder.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Confusional state, Coordination abnormal, Delirium, Electrocardiogram
Clinical narrative: Autoimmune Encephalopahy - Weakness, confusion, delirium, tremors, monoclonal muscle spasms upper and lower extremities, inability to sleep, loss of coordination, loss of cognitive function, inability to control bowel or badder.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electroencephalogram, Endotracheal intubation, Insomnia, Laboratory test, Lumbar puncture
Clinical narrative: Autoimmune Encephalopahy - Weakness, confusion, delirium, tremors, monoclonal muscle spasms upper and lower extremities, inability to sleep, loss of coordination, loss of cognitive function, inability to control bowel or badder.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging, Mechanical ventilation, Muscle spasms, Tremor, Urinary incontinence
Clinical narrative: Autoimmune Encephalopahy - Weakness, confusion, delirium, tremors, monoclonal muscle spasms upper and lower extremities, inability to sleep, loss of coordination, loss of cognitive function, inability to control bowel or badder.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Dizziness, Headache
Clinical narrative: note: type of flu vaccine unknown, flu and shingles vaccine given at same time. moderate to severe headache x ~24 hrs   headache resolved moderate to severe myalga x-24hrs, currently mild to moderate at 48 hrs after injection, improving weakness x 48 hours after injection and continuing but improving stomach discomfort and loss of appetite x24 hrs after injection, improving light headded x 48 hrs and continuing but not as bad after 24 hours, improving
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Myalgia
Clinical narrative: note: type of flu vaccine unknown, flu and shingles vaccine given at same time. moderate to severe headache x ~24 hrs   headache resolved moderate to severe myalga x-24hrs, currently mild to moderate at 48 hrs after injection, improving weakness x 48 hours after injection and continuing but improving stomach discomfort and loss of appetite x24 hrs after injection, improving light headded x 48 hrs and continuing but not as bad after 24 hours, improving
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: I had a stroke on October 5. I had no preexisting conditions such as high blood pressure, high cholesterol, etc.  I never get sick and work out regularly.     I also received the Flucel Vax Quad from Sequirus (Lot 944447) on the same day.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Migraine, Pyrexia, Swelling of eyelid
Clinical narrative: Severe eye swelling underneath and lids, migraines and fever of 103 degrees within 18 hours of injection. Symptoms lasted for 2-3 days.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: High Fever, in the hospital for 3 days.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Age: 36.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Joint range of motion decreased, Mobility decreased, Pain, Tenderness, X-ray
Clinical narrative: Significant pain and loss of range of motion within an hour after shot. Unable to move arm for ~ 3 days. Significant pain has lingered when arm is tweaked over a month later
Age: 68.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain
Clinical narrative: On 10/26, 9:35AM, patient called the pharmacy complaining she has a hard time using her left (L) arm. She can raise her arm up a little, but has to use her other arm to hold it up more. She can?t stretch it out without pain, and is sore to the touch at the injection site. She also mentioned seeing a flu shot commercial (the wolf in sheep?s clothing, Sanofi) about the flu shot, and how you may experience ?muscle weakness?; she went on to say she did not hear the word ?pain? in the commercial, but thought her arm situation might be from getting the shots.  I apologized for what happened to her (I was the one who administered the vaccines Fluad and Shingrix in the L arm.   I contacted  her MD's office and discussed some physical therapy and/or medication therapy recommendations, on 10/26, 11:39AM.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient was given expired vaccination
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Asthenia, COVID-19, Fall, SARS-CoV-2 test positive
Clinical narrative: The patient was brought to the ED by EMS after she sustained a fall on 10/9/23. per staff at the patient's memory care facility, the patient had an unwitnessed fall that day and has since been complaining of pain to the left shoulder and left hip. Additionally, her family reports the patient has been feeling progressively weak. A COVID PCR test was performed which resulted positive. Ultimately, the patient was admitted 10/9/23 - 10/16/23. Discharge diagnosis include COVID-19 infection, among other diagnoses.   The patient has received five COVID vaccines: four doses of Pfizer Monovalent COVID vaccine (given 2/9/21; 3/4/21; 12/23/21; 5/27/22) and one dose of Pfizer Bivalent COVID vaccine (given 12/12/22).
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received 2 vaccines on 9.25.23.  Fluad in her left deltoid and Prevnar 20 in her right deltoid.  Patient stated that nothing was unusual with the way the vaccinations were given, she had no health issues and she was feeling great.  Later that night patient states that her right deltoid turned warm and red and this continued to get worse over the next 3 days.  After 3 days, the site of injection, the right deltoid, turned hard and swelled up to golf ball size.  Today, November 2nd, 2023,  patient states that the spot is extremely painful and she has radiating pain from it.  The pain is interfering with her ability to sleep at night.  She did speak with her provider, who looked at the spot, and the provider was not alarmed and stated to patient that it might just take some time for it to go away completely, that this just happens sometimes.   Patient states that she was already being seen for a different reason, that she did not go to her provider because of the injection site spot.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Sleep disorder
Clinical narrative: Patient received 2 vaccines on 9.25.23.  Fluad in her left deltoid and Prevnar 20 in her right deltoid.  Patient stated that nothing was unusual with the way the vaccinations were given, she had no health issues and she was feeling great.  Later that night patient states that her right deltoid turned warm and red and this continued to get worse over the next 3 days.  After 3 days, the site of injection, the right deltoid, turned hard and swelled up to golf ball size.  Today, November 2nd, 2023,  patient states that the spot is extremely painful and she has radiating pain from it.  The pain is interfering with her ability to sleep at night.  She did speak with her provider, who looked at the spot, and the provider was not alarmed and stated to patient that it might just take some time for it to go away completely, that this just happens sometimes.   Patient states that she was already being seen for a different reason, that she did not go to her provider because of the injection site spot.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: pt received a dose 10/23 of same vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: per pt profile  12/21/22 moderna BIVALENT; SPIKEVAX GIVEN 10/31/2023; DO NOT HAVE PRIOR RECORDS TO BIVALENT
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient Fainted at school.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC20
Symptoms: No adverse event
Clinical narrative: No known reactions
Age: 89.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Lethargy, Urinary incontinence
Clinical narrative: weak, lethargic and urinary incontinence
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Nervousness, Vomiting
Clinical narrative: headache, vomit and shaky