chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Contusion, Feeling cold, Headache, Pain
Clinical narrative: I have never had a seizure in my life before or since, but that morning I had five partial focal seizures in y right arm, over the course of six minutes.  As I was on the phone (to report the first one to my caregiver) when the second hit, I inadvertently punched myself rapidly and repeatedly in the right side of my head, with the phone handset functioning as an impromptu bludgeon, leaving bruises reminiscent of the victim of a fist fight.  Also at the time I had a strong headache, cold chills, a 102 degree Fahrenheit fever and body aches.  None of which persisted beyond noon.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: I have never had a seizure in my life before or since, but that morning I had five partial focal seizures in y right arm, over the course of six minutes.  As I was on the phone (to report the first one to my caregiver) when the second hit, I inadvertently punched myself rapidly and repeatedly in the right side of my head, with the phone handset functioning as an impromptu bludgeon, leaving bruises reminiscent of the victim of a fist fight.  Also at the time I had a strong headache, cold chills, a 102 degree Fahrenheit fever and body aches.  None of which persisted beyond noon.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Extra dose administered, Fatigue, Injection site pain, Musculoskeletal stiffness
Clinical narrative: 2/2/21: injection site soreness, nausea, fatigue 2/3/21: same as 2/2/21 plus body aches, chills, stiff neck 2/4/21: none of the above but now a rash on my hands, feet, underarms, thighs
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Rash, SARS-CoV-2 test negative
Clinical narrative: 2/2/21: injection site soreness, nausea, fatigue 2/3/21: same as 2/2/21 plus body aches, chills, stiff neck 2/4/21: none of the above but now a rash on my hands, feet, underarms, thighs
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Soreness at vaccine site, low grade fever, body aches, fatigue   Improvement with Ibuprofen
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram normal, Feeling abnormal, Hemiparesis, Hypertension
Clinical narrative: See 1st page
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contracture, Neurological symptom, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: See 1st page
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes. Left armpit
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain (minor) the following morning. No other side effects.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain in extremity
Clinical narrative: Roughly about two hours after receiving the first vaccine, my arm started to get sore. At around 9 p.m. I developed chills but no fever. I kept getting random episodes of chills after that. When I went to bed at 10:45 p.m., I had another episode of the chills. I took one teaspoon(half a recommended dose) of Nyquil to help me sleep. I woke up suddenly again with chills and I had a temperature of 100 degrees. I took another teaspoon of Nyquil to help bring down my fever and that helped.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: Symptoms began 1/31, started with feet pain, then achy legs. Pain/muscle aches so bad by 1/1 that she had difficulty walking. Then by 2/2 evening symptoms were completely gone.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: 5 hrs after shot, nauseated, then vomited, diarrhea, chills, no fever
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Itchy rash on both left and right forearms. Started about 24 hours after injection.  Self treated with Benadryl & OTC  1% Cortisone cream Notified family doctor by phone and he advised it was common reaction and not to worry. VA doctor advised to avoid second shot until cleared by allergist & is arranging for consult.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; The VAQTA expired on 1/6/2021 and was administered on 1/8/2021.; This spontaneous report as received from a consumer referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.         On 08-JAN-2021, the patient was vaccinated with expired hepatitis A vaccine, inactivated (VAQTA) (0.5 units not provided, strength, route of administration and anatomical site of vaccination were not reported, lot # was unknown, expiration date reported as 06-JAN-2021) for prophylaxis (expired product administered). No additional adverse events reported.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Acute leukaemia
Clinical narrative: patient was diagnosed with Acute Leukemia 1 week after incorrect administration of Proquad with Pentacel; patient was diagnosed with Acute Leukemia 1 week after incorrect administration of Proquad with Pentacel; This spontaneous report was received from a physician and refers to a 4-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and Hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) (dose, route of administration, anatomical location, indication, lot # and expiration date were not reported).  On an unknown date, 1 week after vaccination, the patient was diagnosed with acute leukemia. The outcome of acute leukemia was unknown.  The causal relationship between suspect therapies and acute leukemia was not reported  Upon internal review, the event of acute leukemia was considered to be medically significant.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; an expired VAQTA was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On 12-JAN-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) dose 1 milliliter, lot # S036494, expiration date 09-JAN-2021 (route of administration and anatomical location were not reported) for prophylaxis. There were no prior temperature excursions of that product. Supported disclaimer was provided. No additional adverse event (AE) was reported.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No further AE; 12 month old patient received both PROQUAD and VARlVAX; 12 month old patient received both PROQUAD and VARlVAX; This spontaneous report as received from a medical assistant refers to a 12-month-old, non-pregnant female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 27-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly, lot # T010314 has been verified to be a valid lot number, expiration date: 24-MAR-2022 (exact dose, anatomical location were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, intramuscularly, lot # T013540 has been verified to be a valid lot number, expiration date: 17-OCT-2021 (exact dose, anatomical location were not reported); both for prophylaxis. Therefore the patient experienced inappropriate schedule of product administration and overdose. The patient was not exhibiting any adverse symptoms and no treatment was given. The outcome of the events was reported as recovered on 27-JAN-2021.
Sex: U
Vaccine: HEP, RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine was administered; Information has been received from a registered nurse referring to a patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant medication were not provided.      On 25-JAN-2021, the patient was administered an improperly stored dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) (1 injection, lot # T004378 has been verified to be a valid lot number for hepatitis b vaccine (recombinant), expiration date reported as 31-OCT-2022, but upon internal validation established as 01-NOV-2022; strength and route were unknown) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 injection, oral, lot # 1688504 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported as 18-NOV-2021, but upon internal validation established as 19-NOV-2021; strength was unknown) for prophylaxis. The vaccines underwent temperature excursions prior to being administered at above 9 degrees Celsius (13.4 degrees Celsius) for 2 hours and 9 minutes (incorrect product storage). There was no previous temperature excursion. The data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Nasal congestion, Respiratory tract congestion
Clinical narrative: massive amount of congestion; This case was reported by a consumer and described the occurrence of respiratory tract congestion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2020 13:00, the patient received Shingrix. On 6th December 2020, less than a day after receiving Shingrix, the patient experienced respiratory tract congestion. On an unknown date, the outcome of the respiratory tract congestion was unknown.   It was unknown if the reporter considered the respiratory tract congestion 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 vaccine indication. The reporter's friend got a shingles shot and had a massive amount of congestion but no fever, also asked if there could be a connection. The congestion was conservatively coded as nasal congestion.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: large red itchy hot circle at the injection site; large red itchy hot circle at the injection site; large red itchy hot circle at the injection site; This case was reported by and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 4th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth 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 vaccine indication. The patient received 2nd injection of Shingrix on Friday morning, 2.5 days before the date of reporting. The patient was experiencing a large red itchy hot circle at the injection site. The patient asked if it was normal.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: I'm allergic to ingredients.; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient allergic to the ingredients of Flu shot. No other information was available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: rash on right hip that itched and tingled; rash on right hip that itched and tingled; This case was reported by a consumer and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced itchy rash and tingling. On an unknown date, the outcome of the itchy rash and tingling were unknown.   It was unknown if the reporter considered the itchy rash and tingling to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and no reaction until 1 month later she developed a rash on right hip that itched and tingled it was not terrible but it lasted for a while 1.5 month. For tolerances of 2nd dose, refer case US2020244414, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244414:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster immunisation, Injection site pain, Pain in extremity
Clinical narrative: Sore arm after receiving a Shingrix shot; This case was reported by a consumer and described the occurrence of injection site pain in a female 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was friend.  The age at vaccination was not reported. The patient was in her 60's and had complained about having a sore arm (at injection site) after receiving a Shingrix shot. No further information was gathered such as the patient's initials or whether it was dose 1 or dose 2(or both).  The reporter also stated that patient did not experience a fever after receiving the Shingrix shot. This is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013457:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014254:Same reporter. US-GLAXOSMITHKLINE-US2021013450:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014110:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore arm after receiving a Shingrix shot; This case was reported by a consumer and described the occurrence of injection site pain in a female 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was friend.  The age at vaccination was not reported. The patient was in her 60's and had complained about having a sore arm after receiving a Shingrix shot. No further information was gathered such as the patient's initials or whether it was dose 1 or dose 2(or both).  The reporter also stated that patient did not experience a fever after receiving the Shingrix shot. This is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013457:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014253:Same reporter. US-GLAXOSMITHKLINE-US2021013450:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014110:Same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Immobile, Lethargy, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: couldn't get up or move; extreme lethargy that was so extreme; panicked because she thought that she had COVID; feeling like she was frozen and she was so cold; fever; didn't get out of bed for two days; This case was reported by a consumer via call center representative and described the occurrence of immobile in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2021 11:00, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2021, less than a day after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant), lethargy, panic reaction, feeling cold, fever and bedridden. On an unknown date, the outcome of the immobile, lethargy, panic reaction, feeling cold and fever were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the immobile, lethargy, panic reaction, feeling cold, fever and bedridden to be related to Shingrix.  Additional details were provided as follows:  After receiving 1st dose of Shingrix, the patient experienced bad reaction that including feeling like she was frozen and she was so cold that she couldn't get up or move and then she got a fever and she didn't get out of bed for two days. The patient also reported that during this experience she was panicked because she thought that she had COVID. The patient described her experience as having extreme lethargy that was so extreme. The patient couldn't move on Saturday and Sunday and then on Monday she felt like she never had anything. The reporter consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Panic reaction, Pyrexia
Clinical narrative: couldn't get up or move; extreme lethargy that was so extreme; panicked because she thought that she had COVID; feeling like she was frozen and she was so cold; fever; didn't get out of bed for two days; This case was reported by a consumer via call center representative and described the occurrence of immobile in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2021 11:00, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2021, less than a day after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant), lethargy, panic reaction, feeling cold, fever and bedridden. On an unknown date, the outcome of the immobile, lethargy, panic reaction, feeling cold and fever were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the immobile, lethargy, panic reaction, feeling cold, fever and bedridden to be related to Shingrix.  Additional details were provided as follows:  After receiving 1st dose of Shingrix, the patient experienced bad reaction that including feeling like she was frozen and she was so cold that she couldn't get up or move and then she got a fever and she didn't get out of bed for two days. The patient also reported that during this experience she was panicked because she thought that she had COVID. The patient described her experience as having extreme lethargy that was so extreme. The patient couldn't move on Saturday and Sunday and then on Monday she felt like she never had anything. The reporter consent to follow up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Haematemesis, Rectal haemorrhage
Clinical narrative: Rectal bleeding; Vomiting blood; A spontaneous report was received from an 84-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced rectal bleeding and vomited blood.  The patient's medical history was not reported. No concomitant medications were reported.  On 11 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 012L20A) intramuscularly, for the prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced rectal bleeding and vomited blood.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, rectal bleeding and vomited blood were considered resolved on 11 Jan 2021.; Reporter's Comments: This case concerns an 84-year-old female patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Rectal bleeding and Vomited blood the same day after receiving their first of two planned doses of mRNA-1273 (Lot 012L20A). Treatment information is not provided. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; A spontaneous report was received from an healthcare professional, regarding a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Myocarditis.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On Unknown date, after receiving the vaccine, the patient experienced Myocarditis. Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, Myocarditis is Unknown.; Reporter's Comments: This case concerns a patient, who experienced a serious unexpected event of myocarditis. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown.  Treatment was not reported. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Given an injection of >.5mL of Moderna COVID-19 vaccine; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was given an injection of more than 0.5mL of Moderna Covid-19 vaccine.     The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the physician reported that a patient was given an injection of greater than .5mL of Moderna Covid-19 vaccine and was seeking advice on what to do.  Action taken with mRNA-1273 in response to the event was not reported.  The event given an injection of more than .5mL of Moderna Covid-19 vaccine was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of Incorrect dose administered.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later; A spontaneous report was received from a consumer, concerning himself, a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later.  The patient's medical history was not provided. Concomitant medications reported included flu quadrivalent shot.  On 22-Jan-2021, prior to the onset of event, the patient received his first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 12-Jan-2021, the patient received flu quadrivalent shot and 10 days later, on 22-Jan-2021, the patient received the Moderna COVID-19 vaccine. Patient also claimed that he was feeling fine. No further information was provided at the time of this report. Reporter provided consent to follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later, was resolved on 22-Jan-2021.; Reporter's Comments: This case concerns a male of unknown age who received his first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection and had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later. There were no reported adverse events after the vaccine was administered in this case of inappropriate schedule of product administration.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Needle separated from the syringe during administration; Was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient; A spontaneous report was received from a nurse, concerning a 73-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and noted needle separated from the syringe during administration and was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient.  The patient's medical history was not reported. Concomitant medications were not specified.  On 07-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 07-Jan-2021, the nurse reported that, the needle got separated from the syringe during administration of the vaccine. Hence, the nurse was able to administer some of the vaccine but was unsure of how much of the dose was given to the patient. The patient has been monitored and no adverse event has been reported. Patient was on concomitant medications but the name of which was not known. No treatment information was reported.    Action taken with mRNA-1273 in response to the events was not reported.   The events, needle separated from the syringe during administration and was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient were considered to be resolved on 07-Jan-2021.; Reporter's Comments: This case concerns a 73 year old male who received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection and noted needle separated from the syringe during administration and was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient. There were no reported adverse events after the study drug was administered in this case of syringe connection issue and incorrect dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Throat tightness
Clinical narrative: Throat started closing; Blood pressure went to 185 over 125; A spontaneous report was received concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat started to close and blood pressure went to 185 over 125.  The patient's medical history included allergies to shellfish. Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On the unknown date, approximately 18 minutes after receiving the vaccine, the patient's throat started to close and her blood pressure went to 185/125 mmHg. The patient had ice packs placed on her and she was hooked up to electrodes. Within 45 minutes, the patient's blood pressure went back down. No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The events, throat started to close and blood pressure went to 185 over 125, were considered resolved.; Reporter's Comments: This case concerns a senior, female patient, with a history of allergies to shellfish, who experienced a serious unexpected event of throat tightness and hypertensive crisis. The events occurred on 1 day (approximately 18 min) after first dose of mRNA-1273, lot # unknown. Treatment included ice pack. Very limited information regarding these events has been provided at this time.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was vaccinated being 16 years old; A spontaneous report was received from a 16-year old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant medications were not provided.  On 21 Jan 2021, the patient received her first dose of two planned doses of mRNA-1273 (Lot Number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient received the mRNA-1273 vaccine at the age of 16-years old.  No treatment for the event was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, patient was vaccinated being 16 years old was considered Resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 16 year old female who received her first dose of two planned doses of mRNA-1273 (Lot Number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events after vaccine was administered in this case of product administered to patient of inappropriate age.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to a 15 year old; A spontaneous report was received from a pharmacist, concerning a 15-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had event vaccine was given to a 15-year-old.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 20-Jan-2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 20-Jan-2021, there might have been a mix up and the 15-year-old patient received the Moderna COVID-19 vaccine instead of the Pfizer vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine was given to a 15-year-old was considered resolved on 20-Jan-2021.; Reporter's Comments: This case concerns a 15-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.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: some of the liquid leaked and fell on patient's arm; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 Vaccine, in which some of the liquid leaked and fell on patient's arm.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 26 Jan 2021, the patient received two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.    On 26 Jan 2021, some of the liquid leaked and fell on patient's arm while receiving their second dose of Moderna COVID-19 vaccine due to the needle not securely attached to the syringe. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event some of the liquid leaked and fell on patient's arm was not reported.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Women might have received a less dose than the recommended because she saw some liquid left in the syringe when the administration of the vaccine was ended; A spontaneous report was received from a consumer concerning a female patient (age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and the woman thought that she might have received a less dose than the recommended because she saw liquid left in the syringe when the administration of the vaccine was ended.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first dose of MRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the woman thought that she might have received a less dose than the recommended because she saw liquid left in the syringe when the administration of the vaccine was ended. No treatment for the event was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, the woman thinks that she might have received a less dose than the recommended because she saw liquid left in the syringe when the administration of the vaccine was ended was not reported.; Reporter's Comments: This case concerns a female patient who received her first dose of MRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and the woman thought that she might have received a less dose than the recommended because she saw liquid left in the syringe when the administration of the vaccine was ended. There were no reported adverse events after the vaccine was administered associated with the event of incorrect dose administered
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: felt that some amount of the vaccine dripped onto her arm; A spontaneous report was received from a pharmacist concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt that some amount of the vaccine dripped onto her arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 25 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Date of first dose of the vaccine was not provided.  On 25 Jan 2021, the patient was given her 2nd dose of the Moderna COVID-19 vaccine and claimed that she felt that some amount of the vaccine dripped onto her arm. Consent to follow up obtained.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, felt that some amount of the vaccine dripped onto her arm, was resolved on 25 Jan 2021.; Reporter's Comments: This case concerns a 63 year old female patient who received her second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection and felt that some amount of the vaccine dripped onto her arm. There were no reported adverse events associated with this case of incomplete dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vial was open for 48 hours in refrigerated condition, administered to patient; A spontaneous report was received from a pharmacist concerning a 32-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and that the vial was open for 48 hours in refrigerated condition and vaccine was administered to patient.   The patient's medical history was not provided. No concomitant medications were reported.   On 24 Jan 2021 at approximately 12:01pm, the patient received first dose of mRNA-1273 (Lot number: 062G20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Jan 2021, a dose of the vaccine was administered after the vial had been in refrigerated conditions for 48 hours. The pharmacist wants to know what the efficacy of a vial that was administered to a patient after 6 hours and is inquiring if the dose should be repeated.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event "the vial was open for 48 hours in refrigerated condition, administered to patient' was not provided.; Reporter's Comments: This case concerns a 32 year old female who received first dose of mRNA-1273 (Lot number: 062G20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and the vial was open for 48 hours in refrigerated condition and vaccine was administered to patient. There were no reported adverse events after the vaccine was administered in this case of product storage error.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Administered to a 16 year old by mistake; Sore arm; A spontaneous report was received from a nurse concerning a 16-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced  sore arm.    The patient's medical history was not provided. Concomitant product use was not reported.  On 23 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient was 16 years of age when she was administered the mRNA-1273 vaccine by mistake. Additionally, the patient experienced a sore arm. No treatment information was provided.   The second dose of mRNA-1273 was discontinued in response to the events. It was reported the patient would be receiving Pfizer's COVID-19 vaccine as their second dose.   The outcome of the event, given vaccine to a 16-year-old by mistake, was considered resolved. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 16 year old female patient received her first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced a non-serious unlisted event of sore arm. There were no other reported adverse events after the vaccine was administered in this event of product administered to patient of inappropriate age. Patient cannot be contacted and no further queries are issued.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Large volume of vaccine ran down arm during the shot; Large volume of vaccine ran down her arm; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and a large volume of vaccine ran down her arm during the shot.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection. During the administration, a large volume of vaccine ran down the patient's arm during her shot. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, large volume of vaccine ran down her arm during the shot, was resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a female patient of unknown age who received her first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection and during the vaccine administration, a large volume of vaccine ran down the patient's arm. There were no reported adverse events after the vaccine was administered in this case of underdose and exposure via skin contact.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Inappropriate administration (drip down arm); dripped down his arm; A spontaneous report was received from a consumer who was a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine was not administered correctly and dripped down his arm.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. While receiving the vaccine, the patient suspected that the vaccine was not administered correctly and dripped down his arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The event, vaccine was not administered correctly and dripped down his arm, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a male patient who received his first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection the vaccine was not administered correctly and dripped down his arm. There were no reported adverse events after the vaccine was administered in this case of Incomplete dose administered and exposure via skin contact.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Product administered at inappropriate site
Clinical narrative: chills from neck to waist; received it up on my shoulder higher than normal; A spontaneous report was received from a consumer who was also a 76-years-old, white, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received it up on my shoulder higher than normal and experienced chills from the neck to waist.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 20 Jan 2021, six days prior to the onset of the event, the patient received their first dose of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient received his vaccine and reported that he "received it up on my shoulder higher than normal".  On 26 Jan 2021, the patient experienced chills from his neck to waist. He felt fine the next day. Treatment for the events, included 3 teapots of Earl Grey Tea, which did not help.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, received it up on my shoulder higher than normal, was not reported. The outcome of the event, chills from the neck to waist, was resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a white male patient who received their first dose of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection and received shot up on shoulder higher than normal and experienced non-serious listed event of chills from the neck to waist. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event of chills, a causal relationship cannot be excluded and the event of chills is possibly related to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine that patient got; Luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine that patient; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine patient got and leaked down the patient's arm.  The patient's medical history was not provided. No concomitant product use was reported.  On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On the unknown date, the luer lock between the syringe and the needle came undone. Some of the vaccine leaked down the patient's arm and was unknown how much of the vaccine the patient actually received. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, the luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine patient got and leaked down the patient's arm, was considered resolved.; Reporter's Comments: This spontaneous report concerns a female patient who experienced a non-serious event of luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine patient got and leaked down the patient's arm (Syringe connection issue and incomplete dose administered ).  The event occurred during the administration of the first dose of the mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown).  There were no reported AEs associated with the events of syringe connection issue and incomplete dose administered.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inadvertently vaccinated an elderly gentleman that had just been vaccinated; A spontaneous report was received from a nurse concerning a male, elderly, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and inadvertently vaccinated an elderly gentleman that had just been vaccinated.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, it was reported that the outreach team inadvertently vaccinated an elderly gentleman that had just been vaccinated on Friday, 22 Jan 2021. The patient had forgotten that had received the vaccine.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, inadvertently vaccinated an elderly gentleman that had just been vaccinated, was resolved.; Reporter's Comments: This case concerns a male elderly patient who received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection, however, the outreach team inadvertently vaccinated an elderly gentleman that had just been vaccinated five days earlier. The patient had forgotten that he had received the vaccine. There were no reported adverse events after the vaccine was administered in this case of inappropriate schedule of vaccine administered.