chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Patient called on 4/9/21 asking about whether side effects from Janssen vaccine should still be present since he had the vaccine on 4/7/21.  Patient said he had fever within 24 hours of the vaccine and was feeling miserable (severe fatigue, chills, fever, nausea, headaches).  He said he was feeling slightly better than the first 24 hours but still feeling really bad. He has been taking Advil which has help slightly.  I advised him to monitor symptoms and to call dr if symptoms get worst and to keep us posted.    I called patient today to follow up with patient and he said that he was not feeling that much better.  He did have a virtual visit with his doctor and was prescribed azithromycin, prednisone, and an inhaler.  Patient has been on medication for a couple of days.  He will continue meds and call us if things do not improve
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient called on 4/9/21 asking about whether side effects from Janssen vaccine should still be present since he had the vaccine on 4/7/21.  Patient said he had fever within 24 hours of the vaccine and was feeling miserable (severe fatigue, chills, fever, nausea, headaches).  He said he was feeling slightly better than the first 24 hours but still feeling really bad. He has been taking Advil which has help slightly.  I advised him to monitor symptoms and to call dr if symptoms get worst and to keep us posted.    I called patient today to follow up with patient and he said that he was not feeling that much better.  He did have a virtual visit with his doctor and was prescribed azithromycin, prednisone, and an inhaler.  Patient has been on medication for a couple of days.  He will continue meds and call us if things do not improve
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Sensation of foreign body
Clinical narrative: Chest pressure at 09:37. Patient given 25 mg Benadryl. At 10:10 patient reported chest pressure and lump in throat. Patient treated with another 25 mg Benadryl.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Blood pressure normal, Blood test normal, Chest X-ray normal, Computerised tomogram normal
Clinical narrative: memory loss of all events that happened that day.  For a 3 hour period patient could not remember what had happened that day at work, his appointments after work, that he had gotten hearing aids 2 weeks prior and that he had ever seen or worn hearing aids.  He was very confused for about 3 hours.  I called our doctor and he advised me to take him to the ER, it took me 45 minutes to get him there and by that time his memory was back.  He has never had a problem like this before and I thought he might be having a stroke or something.  there was definitely something severely wrong.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: memory loss of all events that happened that day.  For a 3 hour period patient could not remember what had happened that day at work, his appointments after work, that he had gotten hearing aids 2 weeks prior and that he had ever seen or worn hearing aids.  He was very confused for about 3 hours.  I called our doctor and he advised me to take him to the ER, it took me 45 minutes to get him there and by that time his memory was back.  He has never had a problem like this before and I thought he might be having a stroke or something.  there was definitely something severely wrong.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Patient developed right arm pain that developed into right forearm numbness and weakness of the right hand. she reports the numbness and tingling and weakness of the right hand has persisted.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain, Peripheral swelling
Clinical narrative: Fever to 100.2 F, heart rate to 107 beats per minute, nausea, severe headache, dizziness, whole body hurt,,arm swelled some
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever to 100.2 F, heart rate to 107 beats per minute, nausea, severe headache, dizziness, whole body hurt,,arm swelled some
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 36 hours
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Nausea, Paraesthesia, Tremor
Clinical narrative: Within 10 min after receiving 2nd dose of vaccine, c/o nausea and feeling dizzy--as if room spinning.  Stated she had this after 1st dose as well little different this time (first dose given at different location) VS --P-96, R-20. unable to obtain b/p as she was shaking--awake and alert . Started to feel somewhat better few minutes later--EMS notified,.  Upon arrival of EMS attempted b/p again w/o success.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Within 10 min after receiving 2nd dose of vaccine, c/o nausea and feeling dizzy--as if room spinning.  Stated she had this after 1st dose as well little different this time (first dose given at different location) VS --P-96, R-20. unable to obtain b/p as she was shaking--awake and alert . Started to feel somewhat better few minutes later--EMS notified,.  Upon arrival of EMS attempted b/p again w/o success.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Malaise, Myalgia, Nausea
Clinical narrative: chills, vomiting, nausea, intense muscle aches, fever, dizziness.  started suddenly around 11pm to midnight, lasted through the night.  in am of 4/13,  still felt ill
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: chills, vomiting, nausea, intense muscle aches, fever, dizziness.  started suddenly around 11pm to midnight, lasted through the night.  in am of 4/13,  still felt ill
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Large red raised rash, approximately 4 in by 4 in; no itching; Symptoms resolved after 3 days, applied ice.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertensive crisis
Clinical narrative: Life-threatening hypertension crisis.  Our doctor prescribed a hydrochlorothiazide 12.5 mg  and potassium tablets.   Did not seem to reduce pressure. Clonidine was administered at The Hospital. The next day our family doctor gave Metoprolol Tartrate, 25 mg which reduced the pressure.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: After getting the Janssen vaccine my hands have been constantly cold. They only get warm after I sit on them for about 10 minutes.  Sticking them under blankets/etc doesn?t help.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Fatigue, Haemoglobin decreased, Lymphocyte count decreased
Clinical narrative: Stable lupus with normal cell counts for years, received second dose Moderna vaccine 4/3/2021 and had 2 days of malaise however then developed increasing fatigue and weakness. Presented to outside hospital on 4/10/2021 and found to have profound thrombocytopenia, mild lymphopenia and anemia.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphopenia, Malaise, Platelet count decreased, Systemic lupus erythematosus, White blood cell count decreased
Clinical narrative: Stable lupus with normal cell counts for years, received second dose Moderna vaccine 4/3/2021 and had 2 days of malaise however then developed increasing fatigue and weakness. Presented to outside hospital on 4/10/2021 and found to have profound thrombocytopenia, mild lymphopenia and anemia.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain, Headache
Clinical narrative: Thought I should let you know I was vaccinated on April 8 with Janssen (J&J).  I had a severe reaction - chest pain and back pain for the entire day.  I alerted Drs., but I'm sure it should be reported.  I took my ZyrtecD prior to vaccine, which I'm sure helped in some manner.  I was better on Friday with lingering back pain.  Today I am down with bad headache and stomach pain, but I am aware there is a current stomach bug.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Decreased appetite, Influenza virus test negative, Legionella test
Clinical narrative: Patient contracted COVID-19 after receiving two doses of Pfizer vaccine. Date of admission approximately 10 week post vaccination. Dates of vaccination unable to be verified as City Immunization Record unable to match with patient. Patient was vaccinated at the a facility. Patient was admitted on 3/31/2021 with ~ 4 days of cough and decreased appetite, found to be COVID positive with pneumonia. Patient received supplemental oxygen, decadron and completed a course of remdesivir. She has improved clinically and was discharged on room air.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 antibody test negative, SARS-CoV-2 test positive
Clinical narrative: Patient contracted COVID-19 after receiving two doses of Pfizer vaccine. Date of admission approximately 10 week post vaccination. Dates of vaccination unable to be verified as City Immunization Record unable to match with patient. Patient was vaccinated at the a facility. Patient was admitted on 3/31/2021 with ~ 4 days of cough and decreased appetite, found to be COVID positive with pneumonia. Patient received supplemental oxygen, decadron and completed a course of remdesivir. She has improved clinically and was discharged on room air.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral artery embolism, Computerised tomogram, Headache
Clinical narrative: My wife was sent to the ER with a headache this morning and has confirmed cerebral embolism
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Headache
Clinical narrative: My wife was sent to the ER with a headache this morning and has confirmed cerebral embolism
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Demyelinating polyneuropathy, Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillian-Barre Syndrome/Acute inflammatory demyelinating polyradiculoneuropathy - ascending paralysis and paresthesias along with autonomic symptoms. Refractory to IVIG. Patient was sent home after course but then continued to worsen and couldn't ambulate . She was readmitted and started on plasmapheresis and pulsed steroids. Respiratory function has been relatively spared, but she has not clearly yet obtained her nadir.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Paraesthesia, Respiratory disorder, Scan with contrast abnormal
Clinical narrative: Guillian-Barre Syndrome/Acute inflammatory demyelinating polyradiculoneuropathy - ascending paralysis and paresthesias along with autonomic symptoms. Refractory to IVIG. Patient was sent home after course but then continued to worsen and couldn't ambulate . She was readmitted and started on plasmapheresis and pulsed steroids. Respiratory function has been relatively spared, but she has not clearly yet obtained her nadir.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Joint swelling
Clinical narrative: Right knee pain, swelling and slight redness
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Facial pain, Headache, Pain in extremity, Throat tightness
Clinical narrative: arm got sore 10 hours after shot,,,,,,,,bad headache at back of my head , check bone real sore, ,teeth hurt,  tightmess  in chest, felt like throat was closing up. That lasted for 4 hours, I took an asperin finally, and it started to subside,
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: arm got sore 10 hours after shot,,,,,,,,bad headache at back of my head , check bone real sore, ,teeth hurt,  tightmess  in chest, felt like throat was closing up. That lasted for 4 hours, I took an asperin finally, and it started to subside,
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, muscle aches, headache, tired, site soreness
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: I experienced extremely severe arm pain both at the inoculation site on my arm and my entire arm was in EXTREME pain. I was unable to move it all for 4 full days and even after the extreme pain subsided, I still had throbbing pain in my arm. Next the pain moved into the shoulder joint of my arm. Now two full weeks after my vaccine, I am still experiencing lingering pain, stiffness and throbbing in my right arm.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I experienced extremely severe arm pain both at the inoculation site on my arm and my entire arm was in EXTREME pain. I was unable to move it all for 4 full days and even after the extreme pain subsided, I still had throbbing pain in my arm. Next the pain moved into the shoulder joint of my arm. Now two full weeks after my vaccine, I am still experiencing lingering pain, stiffness and throbbing in my right arm.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Urticaria
Clinical narrative: 18 welts or raised bumps on upper legs and buttocks
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Sleep disorder
Clinical narrative: Severe headache, chills, significant fatigue, dizziness, unable to sleep. These effects continued for 4 days and subsided on  day 5.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Pain, Pyrexia
Clinical narrative: Patient states fever, tired, body aches, joint pain and dry cough continuing 5 days after vaccination
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: During observation period, patient reported tasting a metal taste in her mouth and throat.  Requested water.  No other symptoms.  Extended observation period,  symptoms did not change, better or worse.  Pt requested further evaluation.  Escorted to Urgent Care on site.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Decreased appetite, Malaise, Nausea
Clinical narrative: Route IM, Right arm 1500 Chills, body aches, fever 101.1, nausea, vomitting, malaise, anxiety, no appetite 1700 Nausea, chills, body aches malaise, anxiety, no appetite 1745 took 12.5mg Promethazine 1800 Fever 102, chills,nausea, body aches, malaise, anxiety/ received order for Zofran. Took 4mg. Zofran and 650mg Tylenol. 1830 Temperature 99.1, nausea subsided, body aches chills subsided, anxiety subsided 2000 Fell asleep 0100 Fever 101.1, chills, bilateral shin pain, body aches; Took 650mg. Tylenol for fever and pain 0600 General malaise no appetite until late afternoon
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Route IM, Right arm 1500 Chills, body aches, fever 101.1, nausea, vomitting, malaise, anxiety, no appetite 1700 Nausea, chills, body aches malaise, anxiety, no appetite 1745 took 12.5mg Promethazine 1800 Fever 102, chills,nausea, body aches, malaise, anxiety/ received order for Zofran. Took 4mg. Zofran and 650mg Tylenol. 1830 Temperature 99.1, nausea subsided, body aches chills subsided, anxiety subsided 2000 Fell asleep 0100 Fever 101.1, chills, bilateral shin pain, body aches; Took 650mg. Tylenol for fever and pain 0600 General malaise no appetite until late afternoon
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache, Influenza like illness
Clinical narrative: "Moderna COVID-19 Vaccine EUA" 4 days after receiving the vaccine I started to have flu-like symptoms of headache, muscle/joint pain, chills, upset stomach, sleepiness, and sinus pain. I am still have these symptoms on day 6, although less severe.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Sinus pain, Somnolence
Clinical narrative: "Moderna COVID-19 Vaccine EUA" 4 days after receiving the vaccine I started to have flu-like symptoms of headache, muscle/joint pain, chills, upset stomach, sleepiness, and sinus pain. I am still have these symptoms on day 6, although less severe.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Headache, Heart rate increased, Pain
Clinical narrative: Fever 102- 104.8, increased heart rate and blood pressure, chills, headache, achy  Symptoms for 24hrs then fever broke Tylenol/Advil and cool towels to reduce fever
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102- 104.8, increased heart rate and blood pressure, chills, headache, achy  Symptoms for 24hrs then fever broke Tylenol/Advil and cool towels to reduce fever
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Itching all over my body that seemed to be moving around inside me
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Lethargy, Nausea
Clinical narrative: No immediate ill effects after this second shot of the Moderna vaccine at 10 am. Worked that day and went home, woke up around 2 am with sweats and nausea and headache which became progressively worse through the day prohibiting any activity. Dry heaves and severe headache with dizziness lasted until 4 pm or so. I did take Ondansetron at 12 noon to limit nausea. Worked the following day with few physical symptoms but very irritable. The next day (Saturday) woke with headache and slight nausea which became worse as the day wore on, limiting activity but I was able to get chores done, though I was very lethargic. The next day was much better. Worked on Monday the 12th of April and felt well. Fell ill again with similar but less severe symptoms, though marked nausea and dry heaving again. Slept until approximately 2pm and started writing this report. 4/13/2021
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Retching, Sleep disorder
Clinical narrative: No immediate ill effects after this second shot of the Moderna vaccine at 10 am. Worked that day and went home, woke up around 2 am with sweats and nausea and headache which became progressively worse through the day prohibiting any activity. Dry heaves and severe headache with dizziness lasted until 4 pm or so. I did take Ondansetron at 12 noon to limit nausea. Worked the following day with few physical symptoms but very irritable. The next day (Saturday) woke with headache and slight nausea which became worse as the day wore on, limiting activity but I was able to get chores done, though I was very lethargic. The next day was much better. Worked on Monday the 12th of April and felt well. Fell ill again with similar but less severe symptoms, though marked nausea and dry heaving again. Slept until approximately 2pm and started writing this report. 4/13/2021
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; A patient received improperly stored vaccine; This spontaneous report was received from a physician and refers to a 16-months-old female patient. Information regarding the patient's concurrent conditions, medical history and historical drugs was not provided.  It was reported that on 24-NOV-2020, the alarm sound were the vaccines were stored it was off and the temperatures were out of range. The vaccines were removed and placed in the pharmacy while they were back in the normal range. Once the temperature was back in range the vaccines were on the office.   On 30-NOV-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) first dose, 0.5 milliliter on the right thigh lot # S021388 and expiration date 09-JUL-2021 administered as prophylaxis.  Concomitant therapies reported administered on the same date included vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and hepatitis A virus vaccine (unspecified).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 37.9 degree fahrenheit (°F) for 7 hours and 12 minutes; no previous temperature excursions were reported.  The call was made due to a digital data logger. No office log was available. No adverse symptoms were reported.  Lot number S021388 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX). Lot number S021388 does not match any company product as confirmed by lot verification team.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: This literature marketed report has been received from authors of the literature article. Acute gastroenteritis (AGE) in hematopoietic cell transplant (HCT) patients caused significant morbidity and mortality. Data regarding the longitudinal assessment of infectious pathogens during symptomatic AGE and asymptomatic periods, particularly in children, were limited. This article investigated the prevalence of AGE-associated infectious pathogens in children undergoing allogeneic HCT.  This report referred to a child of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was unknown.   On an unknown date, the patient vaccinated with 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, lot# and expiration date were unknown) orally for prophylaxis.  On an unknown date (reported as more than 2 years after 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)), the patient underwent HCT (inappropriate schedule of product administration). On an unknown date, the patient performed rotavirus test, however, rotavirus was not identified by real-time reverse-transcriptase polymerase chain reaction (RT-PCR) from the 2 specimens that tested positive by multiplex PCR, which may represent a false positive or low-level shedding.   A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; First dose of ROTATEQ vaccine was administered on 20-MAR-2021 to a 4 month old.; This spontaneous report was received from a nurse, via company representative, referring to a 4-month-old patient of unknown gender.  The reporter did not provide information on the patient's historical drugs, historical conditions, current conditions, and concomitant medications.  On 20-MAR-2021, the patient received the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (route, lot number, and expiration date were not reported) (product administered to patient of inappropriate age). No further adverse events were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs were reported; patient was inadvertently administered 2 doses of VARlVAX within a 4 day time period.; low VARIVAX titer results; This spontaneous report refers to a female patient of unknown age. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported)for prophylaxis. During the visit on 26-MAR-2021, a titer was drawn and the result was low for varicella virus vaccine live (oka/merck)(VARIVAX). On 30-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) again. The outcome of antibody test negative was not reported.  The causality between the event and the varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Cardiac failure congestive, Cardiovascular disorder, Pericarditis
Clinical narrative: congestive heart failure; pericarditis; cardiovascular event; balance problems; Zostavax administered to approximately 49-year-old patient; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 57-year-old patient of an unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 16-SEP-2014, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) at the pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by health care providers for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: pericarditis, cardiovascular event, congestive heart failure, balance problems. The outcome of the events of pericarditis, cardiovascular event, congestive heart failure and balance problems was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of pericarditis and congestive heart failure were determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse events reported; patient received a dose of VARlVAX and the patient wanted ashingles vaccine; This spontaneous report was received from a pharmacist referring to a 68-year-old patient of unspecified gender.    No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 05-APR-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not reported), but the patient wanted a shingles vaccine  (Zoster Vaccine Live (ZOSTAVAX)).  The reporter stated that they were overwhelmed with Coronavirus disease (Covid) vaccines that she did not catch the error before.  No additional adverse events or product quality complaints were reported.  This was one of several patient reports made by the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines with temperature excursions were administered; No additional AE/PQC reported; This spontaneous report was received from a nurse practitioner referring to a 5 years old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the second dose of an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S020961 with an expiration date on 07-JUL-2021) for prophylaxis (strength, dose, anatomical location and route of administration were not reported) (product storage error).  The dose administered experienced a temperature excursión of -58 degrees Fahrenheit (°F) and +46°F (-50 Celsius degrees (°C) to +8°C): above 46°F (46.73°F) for 46 hours and 5 minutes and 0 seconds recorded by a data logger.  There was no previous temperature excursión.  No additional adverse events or product quality complaint were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA002066: US-009507513-2104USA002067:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines with temperature excursions were administered; No additional AE/PQC reported; This spontaneous report was received from a nurse practitioner referring to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S020961 with an expiration date on 07-JUL-2021) for prophylaxis (strength, dose, anatomical location and route of administration were not reported) (product storage error).  The dose administered experienced a temperature excursión of -58 degrees Fahrenheit (°F) and +46°F (-50 Celsius degrees (°C) to +8°C): above 46°F (46.73°F) for 46 hours and 5 minutes and 0 seconds recorded by a data logger.    No additional adverse events or product quality complaint were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA002064: US-009507513-2104USA002067:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines with temperature excursions were administered; No additional AE/PQC reported; This spontaneous report was received from a nurse practitioner referrimg to a 2 month old patient of unknown gemder. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a first dose of an improper stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1707585 with an expiration date on 21-FEB-2022) for prophylaxis (strength, dose, anatomical location and route of administration were not reported) (product storage error).  The dose administered experienced a temperatura excursión of 36°F and 46°F (2°C to 8°C): above 46°F (46.73°F) for 46 hours and 5 minutes and 0 seconds recorded by a data logger.  There was no previous temperature excursión.  No additional adverse events or product quality complaint were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA002066: US-009507513-2104USA002064:
Age: 29.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported; a 29 year old patient received 0.5 milliliters of pediatric VAQTA; a 29 year old patient received 0.5 milliliters of pediatric VAQTA; This spontaneous report was received from a physician referring to a 29 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 22-MAR-2021, the patient was vaccinated with pediatric hepatitis a vaccine, inactivated(VAQTA) (0.5 milliliters, one time dose, lot # T013204, expiration date 03-DEC-2021; strength and route were not reported) for prophylaxis (product administered to patient of inappropriate age and incorrect dose administered). No additional adverse events or product quality complaints were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp  devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: The consumer also reported the side effects as being "uncomfortable"; The consumer reported being itchy, on the arm, as well as experiencing swelling and redness; The consumer reported being itchy, on the arm, as well as experiencing swelling and redness; The consumer reported being itchy, on the arm, as well as experiencing swelling and redness; The consumer reported receiving the second dose, of the PNEUMOV AX 23 vaccine, in 2014, and the first dose in 2011.; This spontaneous report was received from a currently 64 years old female patient, referring to herself. The patient's concurrent condition included multiple sclerosis. The patient's concomitant therapy included bupropion hydrochloride (WELLBUTRIN). The patient was allergic to ampicillin, cephalexin (KEFLEX) and sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA).  On an unknown date in 2011, the patient was received the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, lot# and expiration date were not reported; route was reported as injection) as a prophylactic. On an unknown date in 2014, the patient was received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, lot# and expiration date were not reported; route was reported as injection) as a prophylactic (inappropriate schedule of product administration).  On unknown dates in 2014 (reported as after the 2nd dose), the patient experienced side effects: being itchy, on the arm, as well as experiencing swelling and redness, which had been confirmed by the patient that occurred on the upper arm at the injection site. It was reported that the side effects as being "uncomfortable". No special treatment was given for the events. The outcome of the events was reported as recovered on unknown dates in 2014. The causality assessment between above mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Exposure to SARS-CoV-2, Pulse absent, Respiratory arrest
Clinical narrative: Death Narrative: Patient had Pfizer COVID vaccine dose #1 on 3/20/21. He called his provider on 3/30 to report known exposure to COVID that occurred on 3/27 and 3/28. On 4/1 he tested positive for COVID swabbed at the facility and sent to the main facility for processing. He was notified of positive result on 4/1 at 4pm. He was advised to quarantine and to call facility call center/triage should he develop any fever, shortness of breath, and other Covid-related symptoms. Provider received a phone call from PD on 4/8 notifying of patient unattended death. According to EMS report neighbors were aware of patients COVID positive status. No one had seen or heard from the patient in 3 days so they contacted PD for wellness check. Entry was forced into apartment and patient was found deceased, sitting on the couch. Not breathing ashen color. Pt has ringer and no Pulse. PMH: Quit tobacco 5-15 yrs ago Hyperlipidemia Hyperglycemia Obesity Allergic rhinitis, stable Hx AAA and Right ICA aneurysm, S/P Open repair in 2013 Patient had no prior history of COVID before 4/1 diagnosis. He was not having any symptoms between 4/1 when he tested positive and he did not call to report any symptoms between 4/1 diagnosis and death. There was no communication after 4/1 positive covid test. Patient was scheduled for a phone call with RN on 4/8 the date he was found deceased. Cause of death is not mentioned, but suspected to be due to COVID infection. There were no reported side effects to COVID Vaccine administration.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Skin discolouration
Clinical narrative: Death Narrative: Patient had Pfizer COVID vaccine dose #1 on 3/20/21. He called his provider on 3/30 to report known exposure to COVID that occurred on 3/27 and 3/28. On 4/1 he tested positive for COVID swabbed at the facility and sent to the main facility for processing. He was notified of positive result on 4/1 at 4pm. He was advised to quarantine and to call facility call center/triage should he develop any fever, shortness of breath, and other Covid-related symptoms. Provider received a phone call from PD on 4/8 notifying of patient unattended death. According to EMS report neighbors were aware of patients COVID positive status. No one had seen or heard from the patient in 3 days so they contacted PD for wellness check. Entry was forced into apartment and patient was found deceased, sitting on the couch. Not breathing ashen color. Pt has ringer and no Pulse. PMH: Quit tobacco 5-15 yrs ago Hyperlipidemia Hyperglycemia Obesity Allergic rhinitis, stable Hx AAA and Right ICA aneurysm, S/P Open repair in 2013 Patient had no prior history of COVID before 4/1 diagnosis. He was not having any symptoms between 4/1 when he tested positive and he did not call to report any symptoms between 4/1 diagnosis and death. There was no communication after 4/1 positive covid test. Patient was scheduled for a phone call with RN on 4/8 the date he was found deceased. Cause of death is not mentioned, but suspected to be due to COVID infection. There were no reported side effects to COVID Vaccine administration.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death Narrative: I was told that the patient expired 3 days after his 2nd dose of Moderna vaccine.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fall, Musculoskeletal chest pain
Clinical narrative: death Narrative: Patient with consistent decline over the last year; March 2021- increased confusion related to dementia, falls, hospitalizations wt loss. Enrolled in home hospice on 3/26 family's goal was to keep patient home and comfortable. Patient received J&J vaccine in the home through agency on 4/6/2021, Patient had a fall on 4/7/2021, Patient with rib pain after the fall no other injury noted. Patient passed away on home hospice on 4/11/2021.
Sex: U
Vaccine: HEP, HEP
Symptoms: Unevaluable event
Clinical narrative: Got HEPLISAV-B then got ENGERIX-B; Initial Report Received on 19-Mar-2021  A pharmacist reported that a 25 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then ENGERIX-B one month later.  No relevant medical history or allergies was reported.    No relevant concomitant medications were reported.  On 18-Feb-2021, the patient received a dose of HEPLISAV-B (Lot # 934601, expiration date 16-Mar-2022 and NDC # 803373837456), intramuscularly and the site of administration not reported.   On 18-Mar-2021, 29 days after having been vaccinated with HEPLISAV-B, the patient went to a different pharmacy and got ENGERIX-B (Lot # and expiration date unavailable, NDC # 581600821-52). No adverse reactions to either injection was reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: FLUX, HEP
Symptoms: Fabry's disease
Clinical narrative: Tested Positive for Alpha-Gal; Initial Report Received on 12-Mar-2021  A 51-year old female patient (race and ethnicity not provided) reported that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and tested positive for alpha-gal.  Medical history was reported as type II diabetes, food allergies and pseudocholinesterase deficiency.    No relevant concomitant medications were reported.  On 16-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported), route and site of administration unknown, from a community health center. Concomitant vaccines administered included the flu vaccine (Lot # not reported), route and site of administration not reported.   On an unspecified date after having been vaccinated with HEPLISAV-B, the patient recently tested positive for alpha-gal.  Additional information has been requested.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Hemiparesis, Libido decreased
Clinical narrative: LEFT SIDED WEAKNESS; LESSENED SEXUAL DESIRE WITH SPOUSE; SEVERE ITCHING WITHOUT RASH; LOSS OF APPETITE  (FOOD AND DRINK); EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male.The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and smoker (cigarettes: Half a pack a day), and other pre-existing medical conditions included the patient had no known allergies.The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 on Left Arm for prophylactic vaccination.No concomitant medications were reported.The symptoms appeared on 08-MAR-2021 around 12:00 and had persisted until present. Consisted of headache, severe itching without rash, loss of appetite (food and drink), extreme fatigue, left sided weakness, and lessened sexual desire with spouse. On 2021, treatment medication included: paracetamol and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, severe itching without rash, loss of appetite (food and drink), extreme fatigue, left sided weakness, and lessened sexual desire with spouse. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210410728.; Sender's Comments: 20210409729-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Left sided weakness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: LEFT SIDED WEAKNESS; LESSENED SEXUAL DESIRE WITH SPOUSE; SEVERE ITCHING WITHOUT RASH; LOSS OF APPETITE  (FOOD AND DRINK); EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male.The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and smoker (cigarettes: Half a pack a day), and other pre-existing medical conditions included the patient had no known allergies.The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 on Left Arm for prophylactic vaccination.No concomitant medications were reported.The symptoms appeared on 08-MAR-2021 around 12:00 and had persisted until present. Consisted of headache, severe itching without rash, loss of appetite (food and drink), extreme fatigue, left sided weakness, and lessened sexual desire with spouse. On 2021, treatment medication included: paracetamol and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, severe itching without rash, loss of appetite (food and drink), extreme fatigue, left sided weakness, and lessened sexual desire with spouse. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210410728.; Sender's Comments: 20210409729-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Left sided weakness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia, Somnolence
Clinical narrative: SLEEPY; ACHY JOINTS; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sleepy, achy joints, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleepy, achy joints and slight fever was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Hyperhidrosis, Joint lock
Clinical narrative: SEIZURE; JOINTS LOCKED UP/WHOLE BODY LOCKED UP; NO APPETITE; SWEATING; BARELY BEEN OUT OF BED/HOME BOUND; CHILLS; WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, after 23:00 the patient began shaking and had seizure, her mouth was drawn up. On the same day, the patient experienced fever, chills, sweating, weakness, no appetite and her whole body locked up and her joints locked up. According to the patient, she had barely been out of bed and had been home bound since vaccine was administered. The patient visited doctor/healthcare professional's office for events seizures, shaking, mouth drawn and fever. It was reported that, on 02-APR-2021, a nurse came to the patient's home and tried to encourage her to go to the hospital but she declined. On the day of this report, the patient had an appointment via phone video for her pulmonologist and with her primary care physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joints locked up/whole body locked up on 28-MAR-2021, was recovering from fever, chills, and sweating, had not recovered from seizure, no appetite, and barely been out of bed/home bound, and the outcome of weakness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)