chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Did not get the full dose due to a faulty needle; Did not get the full dose due to a faulty needle; A spontaneous report was received from a pharmacist concerning a 35-year old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the full dose due to faulty needle.  The patient's medical history was not provided. Concomitant product use was not reported.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 19 Jan 2021, during vaccine administration, the patient did not get the full dose due to a faulty needle. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, did not receive the full dose due to faulty needle, was considered resolved on 19 Jan 2021.; Reporter's Comments: This case concerns a 35 year old male patient received their first of two planned doses of mRNA-1273 (Lot Number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection and did not receive the full dose due to faulty needle. There were no reported adverse events after the vaccine was administered in this case of the patient did not get the full dose due to a faulty needle.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Product administered at inappropriate site, Vaccination site induration
Clinical narrative: decent size lump; redness; Vaccine given in the middle of their arm; A spontaneous report was received from a consumer who is a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event of vaccine administered at inappropriate site and experienced descent size lump and redness which seemed to grow.  The patient's medical history was not provided. Concomitant medications were not reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient received vaccine in the middle of her arm. The patient stated that she experienced descent size lump and redness which seemed to grow, which is now stopped but is still there.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, vaccine administered at inappropriate site, was considered resolved and descent size lump and redness which seemed to grow, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced  a product administration error of  product administration at inappropriate site and  non-serious expected events of injection site induration, and  injection site erythema . There were no AEs associated with product administration at inappropriate site. The events of injection site induration, injection site erythema  occurred 1 day (same day) after first dose of mRNA-1273 . Based on the current available information and temporal association between the use of the product and onset of the events  a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Wrong technique in device usage process
Clinical narrative: Didn't get the full dose; saw a bubble in the needle; A spontaneous report was received from a consumer concerning a 75 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced wrong technique in device usage process and didn't get the full dose.  The patient's medical history was not provided.  Concomitant medications were not provided.  On an unknown date the patient received their first of two planned doses of mRNA-1273 (lot number 026C20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient states that when she was getting her first dose she saw a bubble in the needle and wasn't sure if she received a full dose.  Treatment information was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, experienced wrong technique in device usage process and didn't get full dose were considered resolved.; Reporter's Comments: This case concerns a 75 year old female patient who received her first of two planned doses of mRNA-1273 (lot number 026C20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced wrong technique in device usage process and didn't get the full dose. There were no reported adverse events after the vaccine was administered in this case of wrong technique in device usage process and incomplete dose administered. .
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received 1ml instead of 0.5ml on first dose; A spontaneous report was received from a pharmacist, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) 1ml on first dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number: not provided) for prophylaxis of COVID-19 infection.   On an unspecified date, for the first dose, the patient received 1mL of vaccine instead of 0.5mL in one of their clinics and the patient had already received their second dose as well. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event received 1mL on first dose was considered resolved on an unspecified date.; Reporter's Comments: This case concerns a patient of unspecified age and gender who received their first of two planned doses of mRNA-1273 (lot number: not provided) for prophylaxis of COVID-19 infection and received 1mL of vaccine instead of 0.5mL in one of their clinics. There were no reported adverse events after the vaccine was administered in this case of incomplete dose.
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: She thinks the vaccine provider may not have pushed the plunger after she stuck the needle in; A spontaneous report was received from a female consumer of unknown age who received Moderna COVID-19 vaccine on 16-JAN-2021 thought that the vaccine provider may not have pushed the plunger after she stuck the needle in.  The patient's medical history was not provided. The concomitant product use was not provided by the reporter.   On 16 JAN 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route in her left arm for prophylaxis of COVID-19 infection. The patient thought that the vaccine provider may not have pushed the plunger after she stuck the needle in her left arm because the nurse was abruptly distracted. The provider told the patient that after two weeks she could get an antibody test to see if she actually got the vaccine. The patient reported that the establishment where she got her original vaccine was shut down. The patient asked about time frame for receiving the Moderna vaccine. The patient has been advised to reach out to her Healthcare Professional for any concerns which she may had. Treatment information was not provided.  The Action taken with the second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, she thought the vaccine provider may not have pushed the plunger after she stuck the needle in was resolved.; Reporter's Comments: This report refers to a case of Product administration error - wrong technique in device usage process ,for mRNA-1273 , COVID-19 vaccine. There were no reported AEs associated with this case of Product administration error wrong technique in device usage process .
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: May not have received the full dose; A spontaneous report was received from a physician, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and may not have received the full dose.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the physician reported that someone may not have received the full dose.   Action taken with mRNA-1273 in response to the event was not reported.  The event may not have received the full dose was considered resolved on an unspecified date.; Reporter's Comments: This case concerns a patient of unknown age who received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection and may not have received the full dose.  There were no reported adverse events after the vaccine administered in this case of incomplete dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal stiffness, Wrong technique in device usage process
Clinical narrative: Felt like the person didn't puncture her correctly; Arm Felt really Heavy; Stiff neck; A spontaneous report was received from a consumer regarding herself, a 57-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt like the person didn't puncture her correctly, arm felt very heavy and stiff neck.  The patient's medical history was not provided. Concomitant medications were not provided.  On 28 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot Number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, immediately after receiving vaccine, patient felt like the person didn't puncture her correctly (A little bit over the shoulder), hence her arm felt very heavy and had stiff neck.  No treatment for the event was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events felt like the person didn't puncture her correctly was considered resolved on 28 Jan 2021. The outcome of the events, arm felt very heavy and stiff neck were unknown.; Reporter's Comments: This report refers to a case of wrong technique in device usage process (the person didn't puncture her correctly) for mRNA-1273 and concerns a 57 year-old, female patient, who experienced the events of  arm felt very heavy and stiff neck. The events occurred immediately after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Administered the vaccine much lower on her arm about 5 inches below where it was supposed to be injected; A spontaneous report was received from a nurse, concerning herself, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and administered the vaccine much lower on her arm about 5 inches below where it was supposed to be injected.  The patient's medical history was not provided. No concomitant medications were reported.  On 17-Jan-2021, prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273 (lot number 029L20A) intramuscularly in arm for prophylaxis of COVID-19 infection.   On 17-Jan-2021, the vaccine was administered much lower on patient's arm, about 5 inches below where it was supposed to be injected. Treatment information was not provided  Action taken with mRNA-1273 in response to the event was not provided.  The event administered the vaccine much lower on her arm about 5 inches below where it was supposed to be injected was considered resolved on 17-Jan-2021.; Reporter's Comments: This case concerns a 71 year old female patient who received their first of two planned doses of mRNA-1273 (lot number 029L20A) intramuscularly in arm for prophylaxis of COVID-19 infection and the vaccine was administered much lower on patient's arm. There were no reported adverse events after the vaccine was administered in this case of incorrect route of product administration.
Sex: U
Vaccine: COVID19
Symptoms: Out of specification product use
Clinical narrative: Temperature excursion; A spontaneous report was received from a physician concerning twenty patients who received Moderna's COVID-19 vaccine (mRNA-1273) that underwent a temperature excursion   The patients' medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, mRNA-1273 vaccines were exposed to a temperature excursion (peak temperature 51 degrees Fahrenheit) for 1 hour and 18 minutes. It is unknown how long the temperature was at 51 degrees Fahrenheit.  From two (2) vials exposed to temperature excursions, twenty(20) doses were given.  On 12 Jan 2021, the twenty patients received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event, temperature excursion, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of Out of specification product use for mRNA-1273. There were no reported AEs associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccination administered more subcutaneous than intramuscular.; A spontaneous report was received from a consumer of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) more subcutaneous than intramuscular.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of event, the patient received one of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.    On an unspecified date, the patient received a dose of vaccine more subcutaneously than intramuscularly. Treatment information was not provided.  Action taken with mRNA-1273 in response to event was not reported.  The outcome of the event, vaccination administered more subcutaneous than intramuscular was resolved on an unspecified date.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Employee received her second dose of Moderna COVID-19 vaccine 20 days after her first dose; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine, and who received her second Moderna Covid-19 vaccine 20 days after her first dose.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 on an undisclosed date.  On an undisclosed date, the patient received her second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection twenty days after her first dose. Treatment information was unknown.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the event, received her second Moderna Covid-19 vaccine 20 days after her first dose, was resolved.; Reporter's Comments: This case concerns a female patient of unknown age, who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain, Wrong product administered
Clinical narrative: 16 year old inadvertently received the vaccine; sore arm; supposed to receive the Pfizer vaccine but received the Moderna covid-19 vaccine by mistake; A spontaneous report was received from a healthcare professional (HCP) concerning a 16-year-old, female consumer who received Moderna's COVID-19 vaccine  (mRNA-1273) was less than 18 years old and had a sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : 025J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 06 Jan 2021, a 16-year-old patient was inadvertently vaccinated. The patient was supposed to receive Pfizer vaccine but received Moderna COVID- 19 vaccine by mistake. The patient experienced a sore arm but no other known symptoms. No treatment was received for the sore arm.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, vaccine given to a patient less than 18-years-old, and wrong drug administered was considered resolved. The outcome for the patient's sore arm was not reported.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age and Wrong product administered with an associated non-serious expected event of Injection site pain. No treatment received for the event. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Recalled product administered
Clinical narrative: Received 1st dose of Moderna vaccine lot number 041L20A; A spontaneous report was received from a consumer who was also a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received 1st dose of Moderna vaccine lot number 041L20A.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. The lot number was later recalled.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, received 1st dose of Moderna vaccine lot number 041L20A, was resolved on unknown date.; Reporter's Comments: This report refers to a case of a female consumer of an unknown age who received a first dose Moderna's COVID 19 vaccine (Lot # 041L20A), that had been recalled, for prophylaxis of COVID-19 infection. No relevant medical history or con meds were provided. There were no reported AEs associated with this case of female consumer who received a recalled Moderna's COVID-19 vaccine.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: DTaP-IPV Component was administered to a patient without the ActHIB component, with no reported adverse event; Initial information regarding this unsolicited valid non-serious case via  Medical Information (Reference number- 00436605) was received from a physician and transmitted to Sanofi on 19-Jan-2021.  This case involved a patient of unknown age who administered dtap-ipv component without the acthib component (off label use), while patient received vaccines DIPHTHERIA/ TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Past vaccination(s) included MMRVAXPRO.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received DIPHTHERIA/ TETANUS/5 HYBRID AC PERTUSSIS/ IPV (MRC5) /HIB(PRP/T) VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient administered dtap-ipv component without the acthib component (off label use) (latency: unknown) following the administration of suspect vaccine.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  There will be no information available regarding batch number in this case.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus, Vertigo, Vomiting
Clinical narrative: I took the first shot of the Pfizer COVID vaccine on January 16, 2021. Two days later I started to feel a fullness in my left ear. This continued nonstop, save for one day, until January 29, the, after inclining my head at an unnatural angle, I experienced vertigo, vomiting, and intense ringing in my left ear for hours. The following morning, all symptoms were gone. But that afternoon, the ringing in my left ear returned and got progressively worse. The next day, the feeling of fullness in the ear returned as well, and I experienced a second bout of vertigo, and the ringing persists. This suggested that the vaccine has triggered Meniere's disease, a condition that is related to Bell's Palsy, which has also been observed in patients who took the Pfizer COVID vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: Pfizer Covid-19 vaccine treatment under Emergency Use Authorization(EUA): 71 yo female was administered the Pfizer vaccine. During post vaccine monitoring, the patient's entire chest and face were bright read. She had red sponts on her upper chest and shoulders. She reported feeling very hot, but denied any itching, shortness of breath, chest tightness, or itchiness in her throat. Benadryl 50 mg was administered IM into left deltoid. Patient reported allergies to bee stings and IV dye. Vitals were stable. EMS was called and took patient to the hospital per protocol
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Encephalopathy, Transient ischaemic attack
Clinical narrative: TIA (10 minutes of altered consciousness, encephalopathy) while sitting in a chair 6 hours after first Pfizer covid vaccine. Has a h/o similar TIA. No ongoing symptoms sequelae. Advance his anti platelet therapy to plavix and aspirin.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Delusion, Dissociative amnesia, Impulsive behaviour, Judgement impaired
Clinical narrative: [MODERNA COVID VACCINE] treatment under Emergency Use Authorization(EUA):MODERNA COVID VACCINE With second injection patient became very impulsive, and erratic. Dissociative fugue state. Changes in judgement and delusions. Possible neuropsychiatric side effects from the vaccination, which seems perfectly reasonable given potential for severe neuropsychiatric sequelae from actual COVID infection. Drug should possibly include this warning,
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Pain
Clinical narrative: My father got vaccination on 1/26/2020 in the evening and got high temperature and body ache next morning on 1/27/2020 Vaccination was made by pharmacist. My father is also himself PhD Internal Medicine doctor presently practices
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Stated she rec'd the vaccine on Jan 23 & woke up on Jan 31st with a few bumps at the injection site. It progressed over the last couple days & is now the size of a soft-ball. Warm to touch. No pain. No itching. She F/U with her PCP @ Hospital today, 2-3-2021 by telemed appointment. She told her to call this health dept because it was our community clinic where she was vaccinated. Treating with claritin, benedryl, pepsin & an antibiotic now for 5 days. She is planning to get dose number 2 when due (per her PCP as well as HD recommendation)
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: I had the Moderna COVID vaccine on 01/07/21. Thirteen days later I developed a rash-type area on the arm the vaccine was administered into. I photographed it, called my PCP, and have spent the past 10 days trying to figure out how to report it. It should be easier for the general public to be able to report things regarding their health...especially adverse reactions to new products.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: 2nd Moderna vaccination on a Tues. Development of severe posterior thoracic muscle spasms 40-48 hrs later. No known comorbidities. No injury/trauma, exercise or other physical activity to cause injury. Spasms required local heat, NSAIDs, muscle relaxants, rest. Started resolving about 7 days later.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cold sweat, Decreased appetite, Head discomfort
Clinical narrative: body aches, stuffy head, chills with shakiness Temp 101.6 cold sweats, loss appetite x 48 hours
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tremor
Clinical narrative: body aches, stuffy head, chills with shakiness Temp 101.6 cold sweats, loss appetite x 48 hours
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Received 2nd dose moderna vaccination at 7am 1/26 in the left arm. Had mild pain at injection site and some itchiness at the injection site a few days later. I had chin and facial itchiness thinking it was windburn for the next few days and on evening of 2/2 felt upper extremity itching, bilaterally near the elbow. Mostly on the upper left arm. I woke up on 2/3 with itching on both upper and lower extremities with external ear pain and redness and swelling on the same side as my injection. I also had 3-dime to quarter sized hives on the contralateral (right) medial knee and faint rash on other areas where I was experiencing itching throughout my body. No markings notes on trunk. I took cetirizine and symptoms mostly resolved within 30 minutes. I still have mild itching, but no new hives. Seeing provider today in case follow up is required.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Received 2nd dose moderna vaccination at 7am 1/26 in the left arm. Had mild pain at injection site and some itchiness at the injection site a few days later. I had chin and facial itchiness thinking it was windburn for the next few days and on evening of 2/2 felt upper extremity itching, bilaterally near the elbow. Mostly on the upper left arm. I woke up on 2/3 with itching on both upper and lower extremities with external ear pain and redness and swelling on the same side as my injection. I also had 3-dime to quarter sized hives on the contralateral (right) medial knee and faint rash on other areas where I was experiencing itching throughout my body. No markings notes on trunk. I took cetirizine and symptoms mostly resolved within 30 minutes. I still have mild itching, but no new hives. Seeing provider today in case follow up is required.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Upon receiving the Moderna vaccine (1st dose) a significant rash occurred in the area of the injection site. Additionally, a large blister covered the significant rash
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: sore arm tired/weakness
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pneumonia, Pyrexia, SARS-CoV-2 test negative, Viral infection
Clinical narrative: Received Moderna COvid shot #1 01-12-2021, Lot # 039K20A. Began experiencing breathing problems on 01-17-2021. On 01-18-2021, had to be hospitalized with fever of 103 and heart rate of 160. Diagnosed with bilateral pneumonia and an unidentified virus, tested Covid negative.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Extreme weakness, shivering, fever, swollen lymph nodes and feet that feel bruised on the bottom. Feeling of tiredness and lethargic for over three days. My arm where the vaccine was given continues to feel swollen and can hardly be moved.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Lethargy, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Extreme weakness, shivering, fever, swollen lymph nodes and feet that feel bruised on the bottom. Feeling of tiredness and lethargic for over three days. My arm where the vaccine was given continues to feel swollen and can hardly be moved.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Musculoskeletal chest pain, Palpitations
Clinical narrative: My father received first dose of Pfizer vaccine. Within 30 minutes of receiving injection, he experienced heart palpations, high blood pressure,  and pain in his lower right rib cage area. We stayed at hospital for a couple hours until side effects subsided. My father has a heart condition, a liver condition and high blood pressure.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dizziness, Ear pain, Headache
Clinical narrative: Temp                headache Body Aches Dizziness Chills earache sore throat
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Temp                headache Body Aches Dizziness Chills earache sore throat
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Pain, Renal pain
Clinical narrative: T 100.4; body aches; kidney pain
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Moderal chills & pain
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: low grade temp. body aches chills
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills low grade temperature
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weakness
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE,; the vaccine expired 12-SEP-2020 and was administered 18-DEC-2020; This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml, expiration date: 09-DEC-2020 (lot # and route of administration were not reported) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: administration of ROTATEQ after temperature excursion; This spontaneous report was received from a consumer, who was also a patient of an unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and the patient's pertinent medical history was not provided. On 18-JAN-2021, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, orally, for prophylaxis, lot # 1691141, expiry date was not reported, but upon internal validation was established as 01-NOV-2021 (formulation, concentration, dose number, frequency were not reported). The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion at 1. 3degrees of Celsius (C) for 19 minutes, as recorded by the data logger. There was no previous temperature excursion. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia, Incomplete course of vaccination
Clinical narrative: The child had blood in their stool; The father does not want to get any remaining doses of ROTATEQ now; The father does not want to get any remaining doses of ROTATEQ now; child's ROTATEQ; This spontaneous report was received from a nurse practitioner (who obtained information from a patient's father) via a company representative and refers to the child patient of unknown exact age and gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On an unknown day, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown day (after the first dose of the suspect vaccine), the patient had blood in their stool. At that time, their father did not want his child to get any remaining doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The outcome of blood in stool was not reported.  The causality between the event of blood in stool and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.  Upon internal review, blood in stool was considered to be medically significant.  This is one of several reports from the same reporter (MARRS # 2102USA001245).; Sender's Comments:  US-009507513-2102USA001245:
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Can Shingrix cause a rash?; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had rash. The reporter asked could Shingrix cause a rash.
Sex: F
Vaccine: VARZOS
Symptoms: Administration site reaction, Injected limb mobility decreased, Injection site discolouration, Injection site pain
Clinical narrative: injection "was missed administered." / administered too high in the left arm and too close to the shoulder; decreased mobility of the  injected arm; small area turned "black and blue" / Black and blue area at injection site; excruciating pain; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received the 2nd dose of Shingrix. On 4th December 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In December 2020, the patient experienced injected limb mobility decreased, injection site discoloration and pain. The patient was treated with cortisone (non-proprietary) (Cortisone Injection). On an unknown date, the outcome of the injected limb mobility decreased and pain were not recovered/not resolved and the outcome of the injection site discoloration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site discoloration and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got her 2nd Shingrix vaccine and described as the injection was missed administered. The reporter stated that the vaccine was administered too high in the left arm and too close to the shoulder which led to vaccine administered at inappropriate site. The patient has had excruciating pain and decreased mobility of the  injected arm.  A small area turned black and blue. The patient reported she got an injection of Cortisone on On 8th December 2020. The patient stated that the Cortisone has helped but it still not fully recovered. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Heart rate increased, Heart rate irregular, Muscle tightness
Clinical narrative: Throat and neck begun tightening; Heart rate fluctuating up and down for three consecutive times; Fast heart beat; Dizzy; blurry vision; Entire left arm was red; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine, and who experienced feeling throat and neck begun tightening,  heart rate fluctuated up and down for three consecutive times, dizzy, blurry vision, entire left arm was red and fast heartbeat.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included sertraline and levothyroxine sodium.  On 28 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 027J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, patient experienced feeling throat and neck begun tightening, dizzy, blurry vision, entire left arm was red, fast heartbeat and heart rate (135 beats/min) fluctuated up and down for three consecutive times. Treatment included epinephrine injection. Patient was sent to the emergency room for three hours where she was given intravenous fluids.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events, feeling dizzy, blurry vision, entire left arm was red, fast heartbeat and heart rate fluctuated up and down for three consecutive times, was considered recovered/resolved on 28 Dec 2020. The outcome of the event throat and neck begun tightening was not reported.; Reporter's Comments: This spontaneous report refers to a case of a female patient who experienced events of feeling throat and neck begun tightening, dizzy, blurry vision, entire left arm was red, fast heartbeat and heart rate (135 beats per minute) fluctuated up and down.  The events developed on the same day after the administration of the mRNA-1273 vaccine (Lot# 025J20A, expiration date-unknown. Treatment administered include Epi-Pen, IV fluid, normal saline. Outcome is resolving.  Based on the information provided which includes a temporal association, a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Vision blurred
Clinical narrative: Throat and neck begun tightening; Heart rate fluctuating up and down for three consecutive times; Fast heart beat; Dizzy; blurry vision; Entire left arm was red; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine, and who experienced feeling throat and neck begun tightening,  heart rate fluctuated up and down for three consecutive times, dizzy, blurry vision, entire left arm was red and fast heartbeat.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included sertraline and levothyroxine sodium.  On 28 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 027J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, patient experienced feeling throat and neck begun tightening, dizzy, blurry vision, entire left arm was red, fast heartbeat and heart rate (135 beats/min) fluctuated up and down for three consecutive times. Treatment included epinephrine injection. Patient was sent to the emergency room for three hours where she was given intravenous fluids.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events, feeling dizzy, blurry vision, entire left arm was red, fast heartbeat and heart rate fluctuated up and down for three consecutive times, was considered recovered/resolved on 28 Dec 2020. The outcome of the event throat and neck begun tightening was not reported.; Reporter's Comments: This spontaneous report refers to a case of a female patient who experienced events of feeling throat and neck begun tightening, dizzy, blurry vision, entire left arm was red, fast heartbeat and heart rate (135 beats per minute) fluctuated up and down.  The events developed on the same day after the administration of the mRNA-1273 vaccine (Lot# 025J20A, expiration date-unknown. Treatment administered include Epi-Pen, IV fluid, normal saline. Outcome is resolving.  Based on the information provided which includes a temporal association, a causal association cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Some of patient's 2nd dose ran down her left arm; some of the vaccine came out of the syringe and ran down her arm; A spontaneous report was received from a consumer who is a 35-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the vaccine came out of syringe and ran down her arm.  The patient's medical history was not provided. No concomitant product use was reported.  On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: J3202JA) in the left deltoid intramuscularly for prophylaxis of COVID-19 infection. During administration of the vaccine, some of the vaccine came out of the syringe and ran down her arm.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, some of the vaccine came out of syringe and ran down her arm, was considered resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 35 year old female who received her second of two planned doses of mRNA-1273  (Lot number: J3202JA) intramuscularly for prophylaxis of COVID-19 infection and during administration of the vaccine, some of the vaccine came out of the syringe and ran down her arm. There were no reported adverse events after the vaccine was administered in the case of underdose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Was inadvertently given doses of Moderna Covid19 vaccine 18 days apart; A spontaneous report was received from a physician concerning a 61-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was inadvertently given doses of Moderna COVID-19 vaccine 18 days apart.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient received her second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was inadvertently given doses of the Moderna COVID-19 vaccine 18 days apart.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, was inadvertently given doses of Moderna COVID-19 vaccine 18 days apart, was resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 61 year old female patient who received her second of two planned doses of mRNA-1273 (Lot #s: uknown) intramuscularly for prophylaxis of COVID-19 infection and was inadvertently given doses of the Moderna COVID-19 vaccine 18 days apart. There were no reported adverse events reported after the vaccine was administered in the case of inappropriate schedule of product administration.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administering 1st dose of Moderna, COVID-19 vaccine to a 17 years old patient; A spontaneous report was received from a nurse, concerning a 17 year old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and inadvertently administering first dose of Moderna, Covid-19 vaccine to a 17 yeaer old patient.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot #025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the reporter reported that they inadvertently administered first dose of Moderna, Covid-19 vaccine to a 17 year old patient. No adverse events were reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event was considered resolved on 20 Jan 2021.; Reporter's Comments: This case concerns a 17 year old patient received their first of two planned doses of mRNA-1273 (Lot #025L20A) intramuscularly for prophylaxis of COVID-19 infection. There we no reported adverse events after the vaccine was administered in the case of  product administered to patient of inappropriate age.
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: The vial was shook before the patient being vaccinated; A spontaneous report was received from a consumer concerning a 90-years-old, female patient who received Moderna's COVID-19 Vaccine, and the vial was shook before the patient was being vaccinated.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, the vial was shook before the patient being vaccinated. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, the vial was shook before being vaccinated was not reported.; Reporter's Comments: This case concerns a 90 year old female patient who received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and the vial was shook before the patient being vaccinated. There were no reported adverse events after study drug was administered in this case of product use issue.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administering vaccine 11 days apart; A spontaneous report was received from a nurse concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of inappropriate schedule of product administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient received the first dose of the vaccine. The nurse reported that she administered the second dose on the same patient on 16 Jan 2021 and dose 1 and 2 were administered 11 days apart instead of 28 days interval.    No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, inappropriate schedule of product administration, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.