chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysarthria, Dyspnoea, Fatigue, Headache
Clinical narrative: Lightheaded, slurred speech, difficulty forming or saying words, headache, chest pain, shortness of breath, fatigue, couldn't remember how to do things at work that I do everyday, abdominal pain, chills and fever.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pyrexia
Clinical narrative: Lightheaded, slurred speech, difficulty forming or saying words, headache, chest pain, shortness of breath, fatigue, couldn't remember how to do things at work that I do everyday, abdominal pain, chills and fever.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swollen lymph node underneath left armpit. Shot was received on left arm. The area was swollen slightly larger than a golf ball for a little over a week and caused discomfort. The area was tender but there was no physical mass in the swollen area. Was uncomfortable to work with and was treated with ibuprofen and a warm compress.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Nighttime acid reflux - 4 nights in a row
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Myalgia, Rash, Urticaria
Clinical narrative: Fever, Muscle Aches, headache started after 4 hours on Day 1 and continued on Day 2. Fully body rash and hives on Day 3 affecting left arm (not at injection site but hives/rashes mostly affected on this arm). Hives/body rash on legs, hands, torso, back, neck. Redness on face. Have NEVER experienced a rash or hives before. Completely healthy with no allergies.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head, Facial paralysis, Full blood count, Laboratory test normal
Clinical narrative: Pt developed left facial droop and left arm weakness. Diagnosed with Bell's palsy
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Troponin, Urine analysis
Clinical narrative: Pt developed left facial droop and left arm weakness. Diagnosed with Bell's palsy
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever 101.5°, headache, chills, nausea, muscle soreness, joint pain, fatigue
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever 101.5°, headache, chills, nausea, muscle soreness, joint pain, fatigue
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Diarrhoea
Clinical narrative: I'm breastfeeding my 14-month old 3x a day. She had mild diarrhea and mild stomach upset on 5/6 and 5/7. Ruled out no change in diet. Diarrhea is not common for her
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Paraesthesia oral, Throat tightness, Urticaria
Clinical narrative: Within 5-10 minutes of getting my Pfizer vaccine, I started to develop hives on my face, neck and chest. My tongue and lips began to tingle and my throat ached/felt tight. Breathing was not affected. Was monitored for over an hour at pharmacy, and contacted my doctor who instructed me to take a Benadryl. The hives subsided but the tingling in my mouth and the aching in my throat remained. When I got home from pharmacy I took another Benadryl, a Claritin and a Zyrtec. Took a nap from 6:30-8:30 and woke up feeling a lot better. Started feeling the tightness in my throat again around 10:30, so I took another Benadryl
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Extreme diarrhea and nausea
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: NAUSEA AND VOMITING. HAD TO CALL 911. PATIENT WAS LOSING CONCIOUSNESS. PATIENT FELT BETTER AFTER VOMITING AND DID NOT NEED HOSPITAL VISIT. EVEN THOUGH IT WAS RECOMMENDED.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever, Chills, Headache, arm soreness all on the night of vaccination, all lasting for about a day except the fever. The fever stayed over 100F and lasted until May 4th,  7 days after I received the vaccine. I would take acetaminophen , which helped for only a few hours at a time, but the fever never subsided until the following week.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Ocular hyperaemia, Oral herpes
Clinical narrative: On Monday May 3rd I woke up with bloodshot eyes and my lip was starting to swell. It was 12 days after receiving the 1st covid shot. Once Thursday May 6th arrived I was having a full on herpes breakout. Cold sores on my top lip and lesions/fever blisters on my tongue, multiple. I have never had an oral herpes outbreak before in my life so I didn?t even know that I had it in me until now.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site pruritus, Injection site swelling, Lymph node pain
Clinical narrative: I recv'd Pfizer 4/28/21 @ 2pm in my right arm.  I signed up for 'V-Safe,' answered my questions for the 5-6days every afternoon, but on day 7 I had very odd symptoms.  Vaccine site began to hurt, is warm, swollen & itchy, but what hurts the most is my neck, and my Right Lymph node is painful, swollen & hard,  But I was no longer able to report.  I also have headaches related to the Right neck pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: I recv'd Pfizer 4/28/21 @ 2pm in my right arm.  I signed up for 'V-Safe,' answered my questions for the 5-6days every afternoon, but on day 7 I had very odd symptoms.  Vaccine site began to hurt, is warm, swollen & itchy, but what hurts the most is my neck, and my Right Lymph node is painful, swollen & hard,  But I was no longer able to report.  I also have headaches related to the Right neck pain.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: First night 5/4 exhaustion and headache.  Following morning 5/5 exhaustion, headache, pain/lump at injection site. All over muscle and joint pain. By late afternoon fever of 100.3. 5/6 lingering exhaustion. Temp went back to normal early morning hours. Injection site lump with redness, pain, hot to the touch growing. 5/7 Injection site pain, redness, hot to the touch have spread farther along upper arm.  Pain not muscle soreness, feels more like a deep painful bruise. All other symptoms have subsided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: First night 5/4 exhaustion and headache.  Following morning 5/5 exhaustion, headache, pain/lump at injection site. All over muscle and joint pain. By late afternoon fever of 100.3. 5/6 lingering exhaustion. Temp went back to normal early morning hours. Injection site lump with redness, pain, hot to the touch growing. 5/7 Injection site pain, redness, hot to the touch have spread farther along upper arm.  Pain not muscle soreness, feels more like a deep painful bruise. All other symptoms have subsided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Musculoskeletal discomfort
Clinical narrative: Shingles infection. Blisters first appeared May 7 on my left shoulder.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea
Clinical narrative: 1st Pfizer covid shot, gave me heart inflammation, Didn't seek treatment, because It's slowly getting better and it would be a waste of my time. Loss of Breath My heart Literally felt bigger in my chest, The size has decreased but bigger then normal. I think I'll skip the 2nd covid shot out of concern of personal health.
Age: 38.0
Sex: U
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: My husband was the one who was vaccinated by the Pfizer vaccine. I am currently nursing our 16 month old and had not had a period since I became Pregnant with her. One week after my husband received his second vaccine my period is back! I attribute this to the vaccine.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Feeling abnormal
Clinical narrative: Mild fever <100°, mild chills, severe exhaustion, severe body aches, fogginess. This lasted about 36 hours, with the exception of the left hand. The left hand experienced carpal tunnel and arthritis-like symptoms for 6 days longer than all other symptoms. It then went away on its own. To my knowledge, I hadn?t in any way performed stressful or repetitive behaviors leading up to the symptoms; I had been bedridden with the vaccine side-effects and was too exhausted to do much of anything.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: Mild fever <100°, mild chills, severe exhaustion, severe body aches, fogginess. This lasted about 36 hours, with the exception of the left hand. The left hand experienced carpal tunnel and arthritis-like symptoms for 6 days longer than all other symptoms. It then went away on its own. To my knowledge, I hadn?t in any way performed stressful or repetitive behaviors leading up to the symptoms; I had been bedridden with the vaccine side-effects and was too exhausted to do much of anything.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Vomiting
Clinical narrative: Had brain fog around 6 hours after injection. Felt nauseous around 11:30pm and vomited around 12:00pm
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Pupils unequal
Clinical narrative: Right eye drooping about 12 hours after second pfeizer vaccine. Later, noticed that the right pupil is larger than the other.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Intense swelling and injection site pain for 2 days that went away and then came back on day 8 with a hard hot 3-in swollen area below the skin slightly itchy painful to the touch at injection site consistent with what is being called covid arm
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Intense swelling and injection site pain for 2 days that went away and then came back on day 8 with a hard hot 3-in swollen area below the skin slightly itchy painful to the touch at injection site consistent with what is being called covid arm
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Noticed swelling/red "spot" around vaccine site on the night of 5/6; did not hurt or itch but was warm to the touch and about 2-3 inches diameter. By night of 5/7, "spot" was still swollen, slightly itchy (if shirt rubbed it too much), and still did not hurt but had spread to about 4 inches in diameter -- more ovular (longer horizontally than vertically).
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea
Clinical narrative: Patient felt shortness of breath after Prevnar 13 was administered; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A male patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot Number: DL2860; Expiration Date: Nov2022) as single dose for immunisation.  The patient's medical history was not reported. The concomitant medications included Hep A, Hep B and Flu vaccines at the same day with Prevnar 13. Patient felt shortness of breath after Prevnar 13 was administered. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Indicate at which point in the process the medication error occurred: Storage in clinical Practice; No additional adverse events reported/ What was the patient's response? None/ No adverse reaction reported; administration of expired PROQUAD/ expired product inadvertently given/ vaccine was administered 5 days after the expiration date/ Error; This spontaneous report was received from a pharmacist (conflicting information, also reported as from a consumer) regarding an 11-year-old male patient.  According to the pharmacist, the patient did not have any pre-existing physician-diagnosed allergies, birth defects, medical conditions, or illness at the time of vaccination; there was not any other vaccine within four weeks before the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) administration. Concomitant medication included sterile diluent for vaccines.  The pharmacist reported storage in clinical practice medication error (product storage error) (unspecified date).  Subsequent administration error occurred on 30-MAR-2021, when the patient was inadvertently vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (reported as "# of previous doses 0") (1 dose), subcutaneously in the left deltoid, as prophylaxis, five days after the expiration date (lot number S030215, expiration date 25-MAR-2021).   No adverse reactions were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time.; This spontaneous report was received from a nurse practitioner and refers to a 12-month-old patient of unknown gender.  The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) subcutaneous injection (lot number S039319 and expiration date 04-DEC-2021 were verified as valid) (dose and vaccination scheme frequency were unknown; route and anatomical location of vaccination were not reported) for prophylaxis. It was reported that this was the first dose of the vaccine administered to the patient. The vaccine was exposed to a temperature excursion as it was improperly stored at 46.73 Fahrenheit degrees for 46 hours, 5 minutes (product storage error), which was detected by digital data logger. The recommended range temperature was minus 58 Fahrenheit degrees to 46 Fahrenheit degrees. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA002043: US-009507513-2104USA002045: US-009507513-2104USA002042: US-009507513-2104USA002044: US-009507513-2104USA002041:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time; This spontaneous report was received from a nurse and refers to a 23-month-old patient of unknown gender.  The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) subcutaneous injection (lot number S039319 and expiration date 04-DEC-2021 were verified as valid) (dose and vaccination scheme frequency were unknown; route and anatomical location of vaccination were not reported) for prophylaxis. It was reported that this was the first dose of the vaccine administered to the patient. The vaccine was exposed to a temperature excursion as it was improperly stored at 46.73 Fahrenheit degrees for 46 hours, 5 minutes (product storage error), which was detected by digital data logger. The recommended range temperature was minus 58 Fahrenheit degrees to 46 Fahrenheit degrees. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001947:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion/ABOVE 46F (46.73F) for 46 hours 5 minutes and 0 seconds; No additional AE/PQC reported at this time.; This spontaneous report was received from a nurse practitioner and refers to a 6-month-old patient of unknown gender.  The patient's pertinent medical history, drug reactions or allergiesand concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liqud administered orally (lot number 1707585 and expiration date 21-FEB-2022 were verified as valid) (dose and vaccination scheme frequency were unknown) for prophylaxis. It was reported that this was the third dose of the vaccine administered to the patient. The vaccine was exposed to a temperature excursion as it was improperly stored at 46.73 Fahrenheit degrees for 46 hours, 5 minutes (product storage error), which was detected by digital data logger. The recommended range temperature was minus 58 Fahrenheit degrees to 46 Fahrenheit degrees. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001947:
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: 10 year old was given an extra dose of VARIVAX; This spontaneous report was received from a registered nurse referring to a 10-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 16-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter (lot number S021929 has been considered valid, expiration date reported and validated as 15-JUL-2021) for prophylaxis (frequency scheme, route of administration, and anatomical injection site were not reported). At the time of the administration, the patient did not have her vaccination records. Later, the clinic discovered that she was up to date on her vaccines, consequently, she received an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) (extra dose administered).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA003848:
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Condition aggravated, Eructation, Gastrooesophageal reflux disease, Infantile spitting up, Irritability
Clinical narrative: heightened reflux like symptoms; belching; spitting up; fussiness; fever as well around 100 degrees Fahrenheit; This spontaneous report was received from a physician and refers to a 2-month-old male patient.  The patient's concurrent conditions  included being fussy and colic like with belching and spitting up (all started since birth). The patient's mother had cut out dairy to help with these symptoms, and it was helping. His medical history was reported as none, concomitant medications were not reported.   On 09-APR-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter, (lot # 1742457, expiration date reported as 16-JAN-2022, but upon internal validation established as 06-JAN-2022), administered orally for prevention of rotavirus. On the same day, he was vaccinated with  hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (strength, dose, route of administration, lot number, expiry date and indication were not reported) and with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (strength, dose, route of administration, lot number, expiry date and indication were not reported).  On the same day, the patient experienced heightened reflux like symptoms, he was worse again with fussiness (severe), belching and spitting up. He had a fever as well around 100 degrees Fahrenheit for one day after the vaccine. The mother was feeling like he was back to or worse than before he had the vaccine. The patient sought medical attention. No treatment was administered due to the events and no laboratory diagnostics was performed. The outcome of the events was not reported.  The causal relationship between the events and the suspect vaccines was unknown. Since the patient received all suspect vaccines on the same day, the physician was not sure which vaccine or vaccines caused side effects.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: heightened reflux like symptoms; belching; spitting up; fussiness; fever as well around 100 degrees Fahrenheit; This spontaneous report was received from a physician and refers to a 2-month-old male patient.  The patient's concurrent conditions  included being fussy and colic like with belching and spitting up (all started since birth). The patient's mother had cut out dairy to help with these symptoms, and it was helping. His medical history was reported as none, concomitant medications were not reported.   On 09-APR-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter, (lot # 1742457, expiration date reported as 16-JAN-2022, but upon internal validation established as 06-JAN-2022), administered orally for prevention of rotavirus. On the same day, he was vaccinated with  hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (strength, dose, route of administration, lot number, expiry date and indication were not reported) and with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (strength, dose, route of administration, lot number, expiry date and indication were not reported).  On the same day, the patient experienced heightened reflux like symptoms, he was worse again with fussiness (severe), belching and spitting up. He had a fever as well around 100 degrees Fahrenheit for one day after the vaccine. The mother was feeling like he was back to or worse than before he had the vaccine. The patient sought medical attention. No treatment was administered due to the events and no laboratory diagnostics was performed. The outcome of the events was not reported.  The causal relationship between the events and the suspect vaccines was unknown. Since the patient received all suspect vaccines on the same day, the physician was not sure which vaccine or vaccines caused side effects.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event; PNEUMOV AX 23 was inadvertently given to a 12 month old patient.; This spontaneous report was received from a medical assistant and refers to a 12-monts-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 19-APR-2021, the patient was inadvertently vaccinated with a dose of  with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot lumber T035379 with expiration date 31-MAY-2022 (dose, route and anatomical location were not reported) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: MMR II was reconstituted with Normal Saline (0.9%) instead of the supplied Merck Diluent and was administered to a patient; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-APR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # S035356, expiry date 05-NOV-2021 (dose, route of administration, anatomical location were not provided), reconstituted with sodium chloride (normal saline) 0.9 %, lot # 9Y3L4, expiry date 20-MAY-2021 (dose, route of administration were not reported), despite sterile diluent (strength, dose, route of administration, lot # and expiry date were not provided) for prophylaxis.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; Caller reporting a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 12-MAR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form orally administered, as prophylaxis (lot number 1684149 which has been verified to be valid, expiration date reported and validated as 25-JUN-2021) (product storage error). The administered dose of the vaccine was stored at a temperature of 34.1 degrees Fahrenheit (F), during a time frame of 4 hours 15 minutes, as recorded by a digital data logger. There were previous temperature excursions of 34.8 F, during a time frame of 45 minutes; and 34.7 F, during a time frame of 2 hours and 45 minutes. There were no additional adverse events reported in the patient.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007436: US-009507513-2104USA007278: US-009507513-2104USA007276: US-009507513-2104USA007277:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; Caller reporting a temperature excursion / ROTATEQ was administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 26-MAR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form orally administered, as prophylaxis (lot number 1684149 which has been verified to be valid, expiration date reported and validated as 25-JUN-2021) (product storage error). The administered dose of the vaccine was stored at a temperature of 34.1 degrees Fahrenheit (F), during a time frame of 4 hours 15 minutes, as recorded by a digital data logger. There were previous temperature excursions of 34.8 F, during a time frame of 45 minutes; and 34.7 F, during a time frame of 2 hours and 45 minutes. There were no additional adverse events reported in the patient.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007436: US-009507513-2104USA007270: US-009507513-2104USA007278: US-009507513-2104USA007277:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; Caller reporting a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 16-APR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form orally administered, as prophylaxis (lot number 1684149 which has been verified to be valid, expiration date reported and validated as 25-JUN-2021) (product storage error). The administered dose of the vaccine was stored at a temperature of 34.1 degrees Fahrenheit (F), during a time frame of 4 hours 15 minutes, as recorded by a digital data logger. There were previous temperature excursions of 34.8 F, during a time frame of 45 minutes; and 34.7 F, during a time frame of 2 hours and 45 minutes. There were no additional adverse events reported in the patient.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007436: US-009507513-2104USA007276: US-009507513-2104USA007270: US-009507513-2104USA007278:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; Caller reporting a temperature excursion / ROTATEQ was administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 12-APR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form orally administered, as prophylaxis (lot number 1684149 which has been verified to be valid, expiration date reported and validated as 25-JUN-2021) (product storage error). The administered dose of the vaccine was stored at a temperature of 34.1 degrees Fahrenheit (F), during a time frame of 4 hours 15 minutes, as recorded by a digital data logger. There were previous temperature excursions of 34.8 F, during a time frame of 45 minutes; and 34.7 F, during a time frame of 2 hours and 45 minutes. There were no additional adverse events reported in the patient.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007436: US-009507513-2104USA007270: US-009507513-2104USA007277: US-009507513-2104USA007276:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: She states that there was no further adverse event.; A patient was given expired VAQTA; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 22-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA)(strength, route, dose, frequency, and atomical location were unknown) with lot # T014590, and expiration date 15-APR-2021, for prophylaxis. The hepatitis a vaccine, inactivated(VAQTA) vaccine had not had any temperature excursions. The reporter stated that there was no further adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T014590; expirationdate: 15-APR-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
Age: 38.0
Sex: M
Vaccine: HPV9
Symptoms: Influenza like illness, Oropharyngeal pain, Productive cough, Rhinorrhoea, Yawning
Clinical narrative: The patient was also audibly yawning throughout the call.; coughing up productive phlegm; flu-like symptoms / sore throat, and runny nose, but no fever.; these symptoms may indicate they are seroconverting.; This spontaneous report was received from a 38 year old male patient reporting on himself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 22-MAR-2021, 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)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.         Since the first dose, the patient had been experiencing flu-like symptoms, these symptoms were coughing up productive phlegm, sore throat, and runny nose, but no fever. Additionally, at the time of the report in April 2021, the patient was also audibly yawning, and postulated these symptoms may indicate they were seroconverting (vaccine-induced seroconversion).  The outcome of yawning, influenza like illness, productive cough and vaccine-induced seroconversion was unknown.     The reporter did not mention the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion on VARlVAX; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 08-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S025911, expiration date 20-AUG-2021, for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of -58 degree Fahrenheit (°F) and +5 °F (6.3F) for 6 Hours 0 Minutes 30 Seconds and at -58 °F and +5 °F (10.9F) for 7 Minutes 30 Seconds as recorded by a data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Pneumonia, Wheezing
Clinical narrative: Pneumonia; chronic coughing; wheezing; Information has been received from a lawyer referring to a female patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 03-JUL-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered pneumonia and subsequent chronic coughing and wheezing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events pneumonia and subsequent chronic coughing and wheezing was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event pneumonia and subsequent chronic coughing and wheezing to be disability.   Upon internal review, pneumonia was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion on PROQUAD/ had been administered to three patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 07-APR-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # T023918, expiration date 09-JAN-2022 (exact dose, injection site and route of administration were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of -58 and 5 degrees Fahrenheit (6.3 F) for 6 hours and 30 seconds and of -58 and 5 degrees Fahrenheit (10.9 F) for 7 minutes and 30 seconds. The digital data logger was involved in recording the temperature excursion details. Administered dose of vaccine experienced the previous temperature excursion (no details provided). There was no additional adverse events reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA008219:01916440 US-009507513-2104USA008134:01916457
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: threw-up; she is unsure if the patient received any of the medication; This spontaneous report was received from a physician referring to a 2-month-old female patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 28-APR-2021, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, dose, lot number and expiration date were not reported) and then the patient immediately threw-up (vomiting). The physician was unsure if the patient received any of the medication (underdose). This was the infant's first dose. The physician reported the infant was doing well and fully recovered.    The causal relationship between the reported events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a currently 67 or 68-years-old patient (pt.) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 23-OCT-2014, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt. was treated by health care providers (HCP) for herpes zoster. The pt. claimed damages as a result of injuries to itself and economic losses. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Raynaud's phenomenon, Scleroderma
Clinical narrative: postherpetic neuralgia; scleroderma; herpes zoster; Information has been received regarding a case in litigation from a lawyer and referred to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 30-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster, postherpetic neuralgia, scleroderma and Raynaud's disease. As a result of these symptoms, the patient was seen and treated by her medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster, postherpetic neuralgia and scleroderma was considered as not recovered. The causality assessment between the events herpes zoster, postherpetic neuralgia, scleroderma and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the events herpes zoster, postherpetic neuralgia and scleroderma to be disability. Upon internal review, scleroderma was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received dose 1 of GARDASIL and had not received more doses; no adverse event; This spontaneous report was received from a pharmacist doctor referring to a 42 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 24-JUL-2020 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 1 for prophylaxis.  It was reported that the patient did not know that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) required additional doses and so had not received the complete scheme (inappropriate schedule of product administration).  There was no other adverse event reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient had the first dose in August of 2017, and the second dose was administered in April of 2021,; Information has been received from a medical assistant, referring to a 15 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in August 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) (anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis.        Later in April 2021, the patient was received the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  The reporter would like to know about revaccination regarding hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional AE reported; patient received a dose of PROQUAD and a dose of VARlVAX concomitantly; patient received a dose of PROQUAD and a dose of VARlVAX concomitantly; This spontaneous report was received from a pharmacist and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # T037955, expiration date: 09-MAY-2022, 0.5 milliliter (formulation, strength, frequency and route of administration were not reported), concomitantly with varicella virus vaccine live (oka/merck)(VARIVAX) lot# T003707, expiration date: 30-JAN-2022, 0.5 milliliter (formulation, strength, frequency and route of administration were not reported), both for prophylaxis. No additional adverse event was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cardiac disorder, Catheterisation cardiac, Echocardiogram, Magnetic resonance imaging
Clinical narrative: Amnesia; Cardiac disorder; Thrombosis; Transient ischaemic attack; This case was received via another Manufacturer (Reference number: vsafe) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma and Hypothyroidism. Concurrent medical conditions included Stroke. Concomitant products included LEVOTHYROXINE, BRIMONIDINE, LATANOPROST and TIMOLOL for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced AMNESIA (Amnesia) (seriousness criterion hospitalization), CARDIAC DISORDER (Cardiac disorder) (seriousness criterion hospitalization), THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criteria hospitalization and medically significant). At the time of the report, AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Catheterisation cardiac: inconclusive. On 14-Jan-2021, Echocardiogram: inconclusive. On 14-Jan-2021, Magnetic resonance imaging: inconclusive. On 14-Jan-2021, Ultrasound scan: inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The next day, the patient had short term memory loss, patient went to the hospital, and they said patient had some type of heart episode. The patient was taken by ambulance to the hospital and was told  had a blood clot in brain and had suffered a mini stroke. The patient was hospitalized for 4 nights. The patient was given blood thinner and got improved.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.  However patient had an underlying risk in the past history of stroke.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.  However patient had an underlying risk in the past history of stroke.