chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Myocarditis, Pain, Pain in extremity, Pulseless electrical activity, Rhabdomyolysis
Clinical narrative: Approximately 7 days after receiving the Pneumovax vaccine, the patient presented to the Hospital ED 12/2/22 at 18:27  with atypical chest pain. Patient reported bilateral burning leg pain that started ~1 week prior to admission. She states she has also been experiencing full body chills and generalized body aches, and recalls these symptoms starting after receiving her pneumonia vaccine the week prior. In the ED, she was found to have uptrending troponins (583 ->780-> 1019 ->1843 ->2048), hyperkalemia (7.5), and  severely elevated CK (8000s).  Cardiology was consulted 12/2 and found that EKG was notable for peaked T waves and ST depressions in lead II and AVF. Differential diagnosis included ACS vs myocarditis vs elevated troponins secondary to rhabdomyolysis with PE being less likely.  She was given a short course of HD, aspirin, started on a heparin drip, and admitted to the CCU for further management of possible NSTEMI. In the CCU, she received another round of HD, however her potassium remained persistently elevated and troponins continued to climb. On 12/3, the patient went into PEA arrest after which a code blue was called and ROSC was achieved. Patient went into Vfib arrest later the same night and ROSC was achieved again. She was then placed on CRRT for persistently elevated potassium with future planning for an Impella heart pump. Patient went into PEA arrest several more times on the morning of 12/4/22 and the family ultimately decided to make the patient DNR. After the decision was made, the patient went into PEA arrest again and death was pronounced at 14:21 on 12/4/22.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Troponin T increased, Troponin increased, Ventricular fibrillation
Clinical narrative: Approximately 7 days after receiving the Pneumovax vaccine, the patient presented to the Hospital ED 12/2/22 at 18:27  with atypical chest pain. Patient reported bilateral burning leg pain that started ~1 week prior to admission. She states she has also been experiencing full body chills and generalized body aches, and recalls these symptoms starting after receiving her pneumonia vaccine the week prior. In the ED, she was found to have uptrending troponins (583 ->780-> 1019 ->1843 ->2048), hyperkalemia (7.5), and  severely elevated CK (8000s).  Cardiology was consulted 12/2 and found that EKG was notable for peaked T waves and ST depressions in lead II and AVF. Differential diagnosis included ACS vs myocarditis vs elevated troponins secondary to rhabdomyolysis with PE being less likely.  She was given a short course of HD, aspirin, started on a heparin drip, and admitted to the CCU for further management of possible NSTEMI. In the CCU, she received another round of HD, however her potassium remained persistently elevated and troponins continued to climb. On 12/3, the patient went into PEA arrest after which a code blue was called and ROSC was achieved. Patient went into Vfib arrest later the same night and ROSC was achieved again. She was then placed on CRRT for persistently elevated potassium with future planning for an Impella heart pump. Patient went into PEA arrest several more times on the morning of 12/4/22 and the family ultimately decided to make the patient DNR. After the decision was made, the patient went into PEA arrest again and death was pronounced at 14:21 on 12/4/22.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, COVID-19, Eye irritation, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Had a fever, backache and eyes were burning. Took a home COVID-19 test and was positive. Called teledoc and was prescribed PAXLOVID. Took full course and tested negative 3 days later.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Administered on 02/19/2023. The BUD for this vial was 02/18/2023
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Chest discomfort, Fatigue, Flank pain, Influenza virus test negative
Clinical narrative: In early November I had symptoms of tightness in my chest like congestion and feeling fatigued. It lasted for about 10 days. After the first 5 days I had a telemedicine visit. They listed as plank pain that waxes and wanes and does not radiate. Associated symptoms include fever and weakness. Prescribed bedrest with no relief. I had sinus pain and sore throat.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rest regimen, SARS-CoV-2 test negative
Clinical narrative: In early November I had symptoms of tightness in my chest like congestion and feeling fatigued. It lasted for about 10 days. After the first 5 days I had a telemedicine visit. They listed as plank pain that waxes and wanes and does not radiate. Associated symptoms include fever and weakness. Prescribed bedrest with no relief. I had sinus pain and sore throat.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sinus pain
Clinical narrative: In early November I had symptoms of tightness in my chest like congestion and feeling fatigued. It lasted for about 10 days. After the first 5 days I had a telemedicine visit. They listed as plank pain that waxes and wanes and does not radiate. Associated symptoms include fever and weakness. Prescribed bedrest with no relief. I had sinus pain and sore throat.
Age: 60.0
Sex: F
Vaccine: COVID19-2, SMALLMNK, UNK
Symptoms: Asthenia, COVID-19, Cough, Malaise, Myalgia
Clinical narrative: It started with a severe cough, fever, muscle aches, and congestion. I went to the urgent care clinic and got diagnosed with COVID-19. I was given Paxlovid and Tessalon Perles. I also got OTC Mucinex and Mucinex DM. I got better, and then I got sick again. I had a rebound. I called my PCP and was given another prescription for Paxlovid.  At this time, I was also taking Emergen-C, a separate supplement of 1000mg of vitamin C, Xycam, and Flonase nasal spray. The second round of Paxlovid pretty much knocked out my symptoms. At the time of this writing, I feel that I have recovered as much as I am going to from COVID-19, but my energy levels aren't what they were before I got sick.
Age: 60.0
Sex: F
Vaccine: COVID19-2, SMALLMNK, UNK
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: It started with a severe cough, fever, muscle aches, and congestion. I went to the urgent care clinic and got diagnosed with COVID-19. I was given Paxlovid and Tessalon Perles. I also got OTC Mucinex and Mucinex DM. I got better, and then I got sick again. I had a rebound. I called my PCP and was given another prescription for Paxlovid.  At this time, I was also taking Emergen-C, a separate supplement of 1000mg of vitamin C, Xycam, and Flonase nasal spray. The second round of Paxlovid pretty much knocked out my symptoms. At the time of this writing, I feel that I have recovered as much as I am going to from COVID-19, but my energy levels aren't what they were before I got sick.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: A COVID 19 Pfizer Bivalent vaccine was accidentally given as the first dose of a primary series. No adverse events have been reported at this time.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Skin discolouration, Skin warm
Clinical narrative: She came into the pharmacy on 3/13/23 and stated that her arm is now gray after her covid booster.  She said that the day of the vaccine, her skin turned gray-ish in pallor from the top of her shoulder down to her wrist.  She said her arm was sore that day.  She stated that it feels like she has arthritis in her shoulder and pointed to the area of her arm near her armpit on the front of her left arm.   She denied numbness, tingling, or pain.  She also stated that her left hand is warmer than her right hand.  She said her arm is less gray now than it was before,  but is still gray compared to her other arm.  I was not able to assess her arm, but the part of her wrist visible on her left arm was not noticeably different than her right arm.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, Oropharyngeal pain
Clinical narrative: I had a cough spell, very light slight throat, shortness of breath, headache, and fever of 101. By the third day everything was gone except for the cough. The cough lasted for a week. I tested positive for COVID-19 at home. I spoke a doctor and prescribed me Paxlovid. By the fifth day I tested negative.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had a cough spell, very light slight throat, shortness of breath, headache, and fever of 101. By the third day everything was gone except for the cough. The cough lasted for a week. I tested positive for COVID-19 at home. I spoke a doctor and prescribed me Paxlovid. By the fifth day I tested negative.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Chest X-ray normal, Cough, Cystitis
Clinical narrative: On 12/24/2022, Patient presented to the emergency department due to weakness/fall and testing positive for COVID at home; Her COVID NAA test in the Emergency Department also came back positive; She was not hypoxic and chest x-ray was negative. Patient had symptoms of runny nose, sore throat, cough, and body aches since 12/23/2022. Patient was diagnosed with Covid-19 infection, Acute cystitis, Weakness Fall. She was admitted to the hospital for treatment.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fall, Oropharyngeal pain, Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On 12/24/2022, Patient presented to the emergency department due to weakness/fall and testing positive for COVID at home; Her COVID NAA test in the Emergency Department also came back positive; She was not hypoxic and chest x-ray was negative. Patient had symptoms of runny nose, sore throat, cough, and body aches since 12/23/2022. Patient was diagnosed with Covid-19 infection, Acute cystitis, Weakness Fall. She was admitted to the hospital for treatment.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: A COVID 19 Pfizer Bivalent vaccine was given accidentally as the first dose of the primary series. No adverse events were reported at this time.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Covid-19 I tested positive for Covid 19 on December 26, 2022 I experienced fatigue and a fever. I was prescribed PAXLOVID for my symptoms. I started to feel better on January 3, 2023. I tested negative on January 4, 2023 and I tested positive again on January 6, 2023 I then retested and tested negative on January 12, 2023.
Age: 59.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: COVID-19, Chest X-ray normal, Chest discomfort, Cough, Nasopharyngitis
Clinical narrative: I woke up with what I thought was light cold. I had a scratchy throat with a little congestion. About 6:15 PM, I was running a fever 99.0. I tested myself the next night and was positive. I retested because my kit was expired so I tested with a new kit, and it was also positive. I contacted my doctor on February 23, 2023. They advised me to take water and other fluids and over the counter. My cough lasted all the way. My cough had gotten so bad that I thought I had pneumonia. I had a strong pain in my lower left lung. I had a cough the whole 10 days. The chest x-ray was clear. I was given a steroid shot. I felt significantly better the next morning. The chest tightness had gone away. I briefly got the tightness which lasted up until Wednesday or Thursday.
Age: 59.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Pulmonary pain, Respiratory tract congestion, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I woke up with what I thought was light cold. I had a scratchy throat with a little congestion. About 6:15 PM, I was running a fever 99.0. I tested myself the next night and was positive. I retested because my kit was expired so I tested with a new kit, and it was also positive. I contacted my doctor on February 23, 2023. They advised me to take water and other fluids and over the counter. My cough lasted all the way. My cough had gotten so bad that I thought I had pneumonia. I had a strong pain in my lower left lung. I had a cough the whole 10 days. The chest x-ray was clear. I was given a steroid shot. I felt significantly better the next morning. The chest tightness had gone away. I briefly got the tightness which lasted up until Wednesday or Thursday.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Apnoea test, Chronic fatigue syndrome, Fibromyalgia, Insomnia, Laboratory test
Clinical narrative: I had my vaccination on 09/09/2022. In 12/2022 I had been trouble sleeping and went in for a Sleep Apnea test. I went to the rheumatologist and verified that I had fibromyalgia. I feel that it showed up 15 years ago but this was a flare up. I was also diagnosed with Chronic Fatigue System. I am currently being tested for Postural orthostatic tachycardia syndrome and I am waiting on the results.
Age: 44.0
Sex: F
Vaccine: PNC20
Symptoms: Malaise, Pain, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Patient complains of pain and swollen R arm. As per pt she received the pneumonia vaccine yesterday and her arm is really hurting and swollen and seems like it's getting worse.   Per pt she iced the area but it's still really painful.  She was seen by urgent care and placed on antibiotics as a precaution.   Pt sent message to her PCP on 3/13/2023 (Monday morning) stating "My arm swelled up almost double so they gave me antibiotics for some reason. Then yesterday the swelling finally went down but then I got so sick. Threw up and fever all night. I'm much better now though. Anyway they shouldn't give that shot to people. Could you please report it to the manufacturer so they know what it is doing to people. I was in so much pain. Thanks" Pt was placed on nurse triage schedule but has not respond to calls placed to her.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: no symptoms
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation
Clinical narrative: A-fib, referred to cardiologist
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: My husband and I went out to eat with his aunt and uncle. A couple of days later I started to feel a little off but thought I was just getting a cold. A few days later my husband's aunt called to let us know they had tested positive for COVID-19. I took a home COVID-19 test that came back positive immediately. I called my doctor, we discussed that with many medications and sensitivities to many different antibiotics that I would not take the PAXLOVID. I was advised to use over the counter medications. It took me three weeks to get over COVID-19.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Pt states she experienced full body hives as well as slight trouble breathing.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Lethargy, SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 09/10/2022. On 02/28/2023 I had a dry cough and I had extreme lethargy. I tested COVID-19 positive on 02/28/2023 with an at home COVID-19 test. I was prescribed PAXLOVD. I did get rebound COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blood test normal, COVID-19, Chest discomfort, Computerised tomogram normal, Cough
Clinical narrative: It felt like a weight was on my chest. I had shortness of breath, headache, coughing every now and again, and a sore throat. I tested positive for COVID-19 at home. I talked to my doctor, and he was worried about my chest. So, my doctor told me to go to a walk-in clinic. At the walk-in clinic and they did an EKG and blood work. They sent me to the ER, and they did blood work and CAT scan. All the tests came back fine, and they said I just had a mild case of COVID-19 that had a symptom that could have been a problem.
Age: 47.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dyspnoea, Electrocardiogram normal, Headache, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: It felt like a weight was on my chest. I had shortness of breath, headache, coughing every now and again, and a sore throat. I tested positive for COVID-19 at home. I talked to my doctor, and he was worried about my chest. So, my doctor told me to go to a walk-in clinic. At the walk-in clinic and they did an EKG and blood work. They sent me to the ER, and they did blood work and CAT scan. All the tests came back fine, and they said I just had a mild case of COVID-19 that had a symptom that could have been a problem.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Pain, Pyrexia
Clinical narrative: I had a cough, was feverish, achy, very tired, runny nose. I used a home COVID-19 test that came back positive. I called my doctor to have a telehealth visit. I was prescribed PAXLOVID, benzonatate that I started to take immediately. It took six days before I started to feel better. I am feeling better now.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a cough, was feverish, achy, very tired, runny nose. I used a home COVID-19 test that came back positive. I called my doctor to have a telehealth visit. I was prescribed PAXLOVID, benzonatate that I started to take immediately. It took six days before I started to feel better. I am feeling better now.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Rash, Skin warm
Clinical narrative: Rash developed on hands and feet. red, hot to touch.    Menstrual cycle disruption
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: A patient was supposed to receive her Omnipod and received a shipment of VARIVAX and PROQUAD; No adverse Event; This spontaneous report was received from a physician referring to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was supposed to receive her "Omnipod" and received a shipment of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, lot #, expiry date, and route of administration were not provided), the vaccines were supposed to arrive at the clinic of the healthcare professional (HCP), but were packaged with the patient's "Omnipod" and sent to her home address (Drug dispensed to wrong patient). No additional adverse events (AEs) were reported.
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptomatic AE reported; then a year later a fourth one was given; first two doses were given too close together, so the state flagged him as being due for another dose. A third dose was given; This spontaneous report was received from a licensed practical nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-NOV-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial (dose description, and route of administration were not provided), lot #N009801, expiration date: 20-NOV-2019, administered as prophylaxis. On 16-MAR-2018, he was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial (dose description, and route of administration were not provided), lot #N021572, expiration date: 01-MAY-2020, administered as prophylaxis. The reported stated that as the first 2 doses were given too close, he was flagged to being due for another dose; therefore, a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe was given on 09-MAR-2022, (dose description, and route of administration were not provided), lot #U019413, expiration date: 01-NOV-2023, administered as prophylaxis (Inappropriate schedule of product administration). Then, a year later, on 08-MAR-2023, a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe was given (dose description, and route of administration were not provided), lot #W013165, expiration date: 14-DEC-2024, administered as prophylaxis (extra dose administered). No symptomatic adverse events (AE) were reported (no adverse event).
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Illness, Immunisation reaction
Clinical narrative: I got extremely sick; had a reaction to the vaccine; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got extremely sick) and IMMUNISATION REACTION (had a reaction to the vaccine) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got extremely sick) and IMMUNISATION REACTION (had a reaction to the vaccine). At the time of the report, ILLNESS (I got extremely sick) and IMMUNISATION REACTION (had a reaction to the vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. This case contains information for the 12th of 63 patients described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Side effects from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects from the vaccine) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects from the vaccine). At the time of the report, IMMUNISATION REACTION (Side effects from the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the patient-32 out of 63 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Hypersensitivity, Pyrexia
Clinical narrative: Patient had an allergic reaction to second mRNA vaccine.; Hit a fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Patient had an allergic reaction to second mRNA vaccine.) and PYREXIA (Hit a fever of 103) in a 40-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Patient had an allergic reaction to second mRNA vaccine.) and PYREXIA (Hit a fever of 103). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1000 milligram every six hours. At the time of the report, HYPERSENSITIVITY (Patient had an allergic reaction to second mRNA vaccine.) and PYREXIA (Hit a fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that patient had fever of 103 and was told that at 104 would need immediate emergency care and need to take a room temperature shower. This case is reported for 42nd patient out of 63.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Illness, Immunisation reaction
Clinical narrative: They have not been tested enough andall shots made the patient extremely ill; The patient had long term effects; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and IMMUNISATION REACTION (The patient had long term effects) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and IMMUNISATION REACTION (The patient had long term effects). At the time of the report, ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and IMMUNISATION REACTION (The patient had long term effects) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The treatment medication was not reported. The concomitant medication was not reported. The case was reported for patient number 24 out of 63 patients (Bivalent).   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report). This case was linked to MOD-2023-714836 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Illness, Vomiting
Clinical narrative: Throwing up all the time after both doses; I got very sick for 2 weeks; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got very sick for 2 weeks) and VOMITING (Throwing up all the time after both doses) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got very sick for 2 weeks) and VOMITING (Throwing up all the time after both doses). At the time of the report, ILLNESS (I got very sick for 2 weeks) had resolved and VOMITING (Throwing up all the time after both doses) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was provided. This case contains information for the 33 out of 63 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report). This case was linked to MOD-2023-714826 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: throwing up all the time after both doses; I got very sick for 2 weeks; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got very sick for 2 weeks) and VOMITING (throwing up all the time after both doses) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got very sick for 2 weeks) and VOMITING (throwing up all the time after both doses). At the time of the report, ILLNESS (I got very sick for 2 weeks) had resolved and VOMITING (throwing up all the time after both doses) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. This case pertains to Patient 33 out of 63 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report). This case was linked to MOD-2023-714807 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination site reaction
Clinical narrative: They have not been tested enough andall shots made the patient extremely ill; Patient had long term attects; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and VACCINATION SITE REACTION (Patient had long term attects) in a 48-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and VACCINATION SITE REACTION (Patient had long term attects). At the time of the report, ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and VACCINATION SITE REACTION (Patient had long term attects) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The treatment medication was not reported. The concomitant medication was not reported.  The case belongs to patient number 24 out of 63 patients  (monovalent).   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report). This case was linked to MOD-2023-714802 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypersensitivity
Clinical narrative: I had an allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (I had an allergic reaction) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (I had an allergic reaction). At the time of the report, HYPERSENSITIVITY (I had an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported. This case contains information for the 25th of 63 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master Case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Depression, Lung disorder, Pneumonia, SARS-CoV-2 test
Clinical narrative: Covid-19 damaged her lungs - Side effects are short of breath, problems breathing, coughing spells; Depression; Pneumonia; Had Covid-19 in August 2022; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (Pneumonia) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Non-smoker.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In August 2022, the patient experienced COVID-19 (Had Covid-19 in August 2022). In October 2022, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced LUNG DISORDER (Covid-19 damaged her lungs - Side effects are short of breath, problems breathing, coughing spells) and DEPRESSION (Depression). At the time of the report, PNEUMONIA (Pneumonia), LUNG DISORDER (Covid-19 damaged her lungs - Side effects are short of breath, problems breathing, coughing spells), DEPRESSION (Depression) and COVID-19 (Had Covid-19 in August 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had Covid-19 in August 2022 and then caught with Pneumonia in October-2022. They had a Doctor visit on 07-MAR-2023 and the doctor said that Covid-19 damaged her lungs. Side effects were short of breath, problems breathing, coughing spells, depression.  At the time of reporting, patient was on inhaler usage.; Reporter's Comments: Company comment: This spontaneous case concerns a 70-year-old female patient with no relevant medical history who experienced the serious (medically significant) unexpected event of Pneumonia which occurred unknown days after receiving first dose of mRNA-1273 vaccine. It was also reported that patient was diagnosed with COVID-19, 2 months prior to diagnosis of pneumonia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19-2
Symptoms: Colitis microscopic, Headache, Pain in extremity
Clinical narrative: her arm was so sore for a full day; headache; lymphocytic colitis; This spontaneous case was reported by a patient and describes the occurrence of COLITIS MICROSCOPIC (lymphocytic colitis) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COLITIS MICROSCOPIC (lymphocytic colitis) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm was so sore for a full day) and HEADACHE (headache). At the time of the report, COLITIS MICROSCOPIC (lymphocytic colitis), PAIN IN EXTREMITY (her arm was so sore for a full day) and HEADACHE (headache) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that over 55 years old patient was diagnosed with lymphocytic colitis in January. She stated that her arm was so sore for full day and a headache. She was not clear to which dosage it was but she received all 4 doses. No treatment drug details was reported.  Company comment: This spontaneous case concerns an elderly female patient of an unspecified age, with no medical history reported, who experienced the unexpected serious (medically significant) event of Colitis microscopic (Lymphocytic colitis) that occurred in the context of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available. No further information regarding risk factors, clinical course, medical history, concurrent conditions, concomitant medication, additional vaccination details, investigations and treatment received were provided. The outcome of the event was recovered. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Deafness
Clinical narrative: a patient that regained hearing after experiencing hearing lost from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (a patient that regained hearing after experiencing hearing lost from the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (a patient that regained hearing after experiencing hearing lost from the vaccine) (seriousness criterion medically significant). At the time of the report, DEAFNESS (a patient that regained hearing after experiencing hearing lost from the vaccine) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (medically significant) event of Deafness; onset latency unknown after receiving a dose of mRNA-1273.222 bivalent vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event was available in the report. The patient regained hearing. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714609 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714609:Same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient was given a vaccine past the beyond use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was given a vaccine past the beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     It was unknown that patient receive other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was given a vaccine past the beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was given a vaccine past the beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A patient was given a vaccine past the beyond use date).    No concomitant medication details was reported. No treatment medication details was reported.  It was reported that Moderna Bivalent for 12years was prepared into a syringe and stored in a refrigerator for 15 hours and 37 minutes prior to administration to the patient. The vial had not been involved in any prior temperature excursions, and the prepared syringe was stored in the refrigerator without excursion for that duration. One patient was impacted and received the syringe dose past the syringe beyond use date.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Primary series). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 06-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer Bivalent on 27-Sep-2022 and Moderna Bivalent on 06-Mar-2023).    No concomitant medications were reported.  On 27-Sep-2022, patient received Pfizer Bivalent.  No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023; No adverse event; Patient had dose administered after 30-day Use By Date or after manufacturer date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023).    Concomitant drugs were not reported.  It was reported that bivalent vial of unknown size was administered to 5 patients after 30 days use by date. The vial never underwent any temperature excursions. No adverse reaction was reported by patient at that time.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-714731, US-MODERNATX, INC.-MOD-2023-714729 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714729:Same reporter US-MODERNATX, INC.-MOD-2023-714731:Same reporter