chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pain in extremity, Peripheral swelling
Clinical narrative: left side of her face is red since waking up; itching around the injection site; pain in left arm; swelling in the left arm; redness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number J79G7, expiry date 27th August 2022) for prophylaxis.   Concurrent medical conditions included penicillin allergy (allergic to Amoxicillin) and allergic reaction to drug (allergic to isoamylalcohol).   On 27th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, swelling arm and injection site erythema. On 28th November 2020, the patient experienced injection site itching. On 2nd December 2020, the patient experienced red face. The patient was treated with loratadine (Claritine). On an unknown date, the outcome of the injection site itching, swelling arm and injection site erythema were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the red face was unknown.   It was unknown if the reporter considered the injection site itching, pain in arm, swelling arm, injection site erythema and red face to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received the 1st dose of the Shingrix vaccine in the left arm.  The patient reported that same day after receiving the vaccine she had pain in the left arm, redness around the injection site that was a 4 to 5 inch area going down from the injection site, and swelling in the left arm.  The Patient reported the pain has resolved.  The patient reported the redness around the injection site and the swollen arm is still ongoing.  The patient reported itching around the injection site began and was not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product
Clinical narrative: Vaccine got on the nurse who administered vaccine; A spontaneous report was received from a nurse concerning a 58-year-old nurse, who administered the Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine got on the nurse who administered the vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, the nurse administered the vaccine to a patient who received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) for prophylaxis of COVID-19 infection.   On 11 Jan 2021, as the nurse was administering the vaccine to a patient, the hub of the syringe came off while in the patient's arm and some of the vaccine got on the nurse.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine got on the nurse who administered vaccine, was resolved on 11 Jan 2021.; Reporter's Comments: This report refers to a case of Accidental exposure to product for COVID -19 vaccine( mRNA-1273), lot # 011L20A. There were no reported AEs associated with this case of Accidental exposure to product COVID -19 vaccine( mRNA-1273).
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Needle came out of the syringe whlie applying vaccine; A spontaneous report was received from a healthcare professional concerning a 59 year old male patient who was participating in the mRNA-1273 Emergency Use Program and experienced the needle came out of the syringe while applying vaccine.   The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications reported included two diabetes medications and HMG COA reductase inhibitor.  On 11-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot 011L02A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 11-Jan-2021, the needle came out of the syringe while applying vaccine and it came off in the patient's arm. It is unknown how much of the vaccine the patient received but reports there was a lot of liquid on his pants and arm.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event, needle came out of the syringe while applying vaccine was considered recovered on 11-Jan-2021.  The reporter did not provide a causality assessment of the event needle came out of the syringe while applying vaccine.; 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. Reported event is unlisted for mRNA-1273  and causality was assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vial was punctured more than 6 hours before administration; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial that was punctured more than 6 hours before administration.    The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On an 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 vial used for the patient's vaccine had been punctured for more than 6 hours before administration. No treatments were administered for the event.    Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, vial was punctured more than 6 hours before administration, was considered resolved.; Reporter's Comments: This report refers to a case of patient of unknown age who received the first dose of the vaccine from a  vial that had been punctured for more than 6 hours before administration of mRNA-1273 (Lot# unknown). There were no reported AEs associated with this event of "the vial used for the patient's vaccine was punctured more than 6 hours before administration."
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 1 ml of vaccine administered; A spontaneous report was received from a health care professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 1 ml of vaccine was administered.   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: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient received a 1 ml dose of the Moderna COVID-19 vaccine, instead of 0.5 ml, during their first dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, 1 ml of vaccine was administered, was considered resolved on unknown date.; 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Redness at injection site; Tenderness at injection site; Might have gotten the vaccine subcutaneously; Itching at the injection site; Hard injection site; A spontaneous report w was received from a nurse concerning herself, a 66-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and might have received the vaccine subcutaneously and experienced itching at the injection site itching, redness, a hard injection site and tenderness at the injection site.  The patient's medical history included an allergy (unknown) and high blood pressure. Concomitant medications included cetirizine, famotidine, losartan, folic acid, calcium, ascorbic acid, and cyanocobalamin.   On 02-Jan-2021, a few hours prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   A few hours after receiving the vaccine, the patient started to feel itching at the injection site. Later that same night, she developed redness and the injection site became hard and a little tender. The following day the reaction was worse and lasted for four days By 06-Jan-2021 the reaction was gone but appeared again and lasted until 11-Jan-2021. She also mentioned that the needle used for the injection was 25-gauge needle so she believed she may have received the vaccine subcutaneously.   Treatment for the events included hydrocortisone cream.    Action taken with mRNA-1273 in response to the event was not provided.   The outcomes of the event, might have received the vaccine subcutaneously, was resolved on 02 Jan 2021. The events, itching at the injection site itching, redness, a hard injection site and tenderness at the injection site, were considered resolved on 11 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old, female patient, with history of allergy and hypertension, who experienced a non-serious unexpected event of incorrect route of product administration, injection site pruritus, injection site induration, non-serious expected events of, injection site erythema and injection site pain. There was no AEs associated with incorrect route of product administration. The events of, injection site pruritus, injection site induration, injection site erythema, and injection site pain, occurred 1 day (same day) after first dose of mRNA-1273, lot # 025L20A. Treatment included cortisone cream. Based on the current available information and temporal association between the use of the product and onset of the events (injection site pruritus, injection site induration, injection site erythema, injection site pain), a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vial punctured 24 hours or even 48 hours prior to being adminstered; A spontaneous report was received from a nurse who was also a 31-years-old, female patient who received Moderna's COVID-19 Vaccine and who experienced the event, vial punctured 24 or even 48 hours prior to being administered.  The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 vaccine (Lot 039K20A) intramuscularly for prophylaxis of COVID-19 infection on 06 Jan 2021. The patient noted that the vial was punctured for 24-48 hours before the vaccine content was administered to her.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, vial punctured 24 or even 48 hours prior to being administered, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 31-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 039K20A), reporting Out of specification product use without any associated adverse events.
Sex: M
Vaccine: FLUX
Symptoms: Chronic sinusitis, Influenza, Pneumonia
Clinical narrative: flu; pneumonia; chronic sinus infection; Initial information received on 16-Jan-2021 regarding an unsolicited valid serious social media case received from a consumer.  This case involves male patient who experienced flu (influenza), Pneumonia, chronic sinus infection (chronic sinusitis), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza), Pneumonia, chronic sinus infection (chronic sinusitis)  (Unknown latency) following the administration of INFLUENZA VACCINE. Pneumonia was assessed as medically significant as per important medical event list. The patient was hospitalized for these events.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for all events.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves male patient of unknown age who experienced flu (influenza), Pneumonia, chronic sinus infection (chronic sinusitis), while he received vaccine INFLUENZA VACCINE from unknown manufacturer. The time to onset is also unknown. There is, moreover, no information regarding patient's medical history, condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of suspect vaccine cannot be assessed.
Age: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok had been administered to 3 year old patient with no AE; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old patient who received a 0.5 ml dose of vaccine QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] prefilled syringe (lot: UJ509AA, expiry date: 10-May-2021), via intramuscular route at the left deltoid, on 29-Dec-2020 (Product administered to patient of inappropriate age)  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration. (Latency same day). It was reported nurse with question regarding administration of FLUBLOK to patients under 18 years of age. Caller reported FLUBLOK had been administered to 11 patients and would like to know if they are "covered" for influenza vaccination for the season   At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Leukaemia
Clinical narrative: childhood leukemia; Initial information regarding an unsolicited valid serious case was received from a pharmacist (Reference number- 00434394) and transmitted to Sanofi on 18-Jan-2021.  This case involves a 4-year-old patient (unknown gender) who experienced childhood leukemia (leukaemia), while the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, past medical treatment, family history and concomitant medication were not reported.  The patients past vaccination included HIB vaccine for prophylactic vaccination (reported as preiously received a full series of Haemophilus influenzae type b (Hib) vaccine).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (batch number and expiration date were not reported) via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced childhood leukemia (leukaemia) (latency: unknown) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant.  The reporter asked if Pentacel had ever been implicated as a potential cause of childhood leukemia and any side effects were anticipated if a 4-year-old patient received one dose of Pentacel after previously receiving a full series of HIB vaccine.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the events was reported as unknown.  Information about batch number requested.; Sender's Comments: Sanofi company comment on 22-Jan-2021: This case concerns a 04-year-old patient who experienced leukaemia after vaccination with PENTACEL. The time to onset is compatible. Further information regarding medical condition at the time of vaccination, previous vaccinations and laboratory investigations excluding alternative etiologies is needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy, Migraine, Nausea
Clinical narrative: I am 10.5 weeks pregnant, was about 9 weeks at time of vaccination. I was experiencing lots of nausea and body aches before vaccine, as well as morning sickness. Friday, the day after the vaccine, I had a splitting migraine with dizziness and nausea from Friday to Monday afternoon. The pregnancy symptoms stopped as well, and i have an appointment on Feb 5th for a checkup with my doctor to check the baby.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site irritation, Peripheral swelling
Clinical narrative: redness/swelling /irritation  to upper arm- MD treating with ABT Levaquin x 7 days
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis
Clinical narrative: Patient verbalized cold chill after receiving the vaccine.  Patient was evaluated by onsite HCP and released home 11:49 am.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Client verbalized feeling dizzy and nauseous after receiving the vaccine.  Client was evaluated.  Client was hydrated and place in a cool environment until resolved.  Client was cleared at 2:57 pm.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Pain in extremity
Clinical narrative: Received shot at 3/4 PM, left arm started hurting at 6 AM and throat felt extremely parched. At 10 o'clock started dry coughing periodically throughout the day. Symptoms disappeared 2 days after receiving the COVID injection.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest X-ray, Chest pain, Chills, Computerised tomogram
Clinical narrative: First day I was lightheaded, dizzy, sore all over, weak and had the chills. The second day i had severe chest pain and trouble breathing, I went to the ER and was admitted into the hospital because of this. After an EKG it was found that I had Myocarditis. To treat it they gave me an IV for the pain, then I was prescribed ibuprofen and 2 other meds for the inflammation around my heart.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram abnormal, Myocarditis, Pain
Clinical narrative: First day I was lightheaded, dizzy, sore all over, weak and had the chills. The second day i had severe chest pain and trouble breathing, I went to the ER and was admitted into the hospital because of this. After an EKG it was found that I had Myocarditis. To treat it they gave me an IV for the pain, then I was prescribed ibuprofen and 2 other meds for the inflammation around my heart.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: First day I was lightheaded, dizzy, sore all over, weak and had the chills. The second day i had severe chest pain and trouble breathing, I went to the ER and was admitted into the hospital because of this. After an EKG it was found that I had Myocarditis. To treat it they gave me an IV for the pain, then I was prescribed ibuprofen and 2 other meds for the inflammation around my heart.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Pain, SARS-CoV-2 test negative
Clinical narrative: First day I was lightheaded, dizzy, sore all over, weak and had the chills. The second day i had severe chest pain and trouble breathing, I went to the ER and was admitted into the hospital because of this. After an EKG it was found that I had Myocarditis. To treat it they gave me an IV for the pain, then I was prescribed ibuprofen and 2 other meds for the inflammation around my heart.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Vomiting
Clinical narrative: Severe diarrhea,  severe vomiting ,  severe headaches and chills
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm day 1 headache started on 1/7 and have progressively gotten worse.   1/20 did virtual visit with PCP and was started on Flexeril and 800mg motrin.  No relief from either.  Stopped Motrin 1/22 and was prescribed Prednisone 30mg x 3 days, 20mg x 3 days and 10mg x 3 days.  Headaches have become almost constant at this point.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: From 12 Jan to the current date of Jan 25 I have had an intense headache.  The headache varies from severe to bearable, but has not cleared up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Malaise
Clinical narrative: I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Thirst, Throat tightness
Clinical narrative: I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity, Pharyngeal swelling, Sneezing, Swelling face
Clinical narrative: I stayed for 15 minutes after injection, then when in my car driving home I felt mild swelling in my throat. No other symptoms at that time. Symptoms resolved by that afternoon when I woke up to go to work. The Next day 24 hours after injection I had Severe allergic reaction after eating. Hives, significant throat swelling, sneezing, eyes and face swelling. I took Fexofenadine, Benadryl, Prednisone and went to the doctor where I got an injection on Steroids and more oral Prednisone.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I stayed for 15 minutes after injection, then when in my car driving home I felt mild swelling in my throat. No other symptoms at that time. Symptoms resolved by that afternoon when I woke up to go to work. The Next day 24 hours after injection I had Severe allergic reaction after eating. Hives, significant throat swelling, sneezing, eyes and face swelling. I took Fexofenadine, Benadryl, Prednisone and went to the doctor where I got an injection on Steroids and more oral Prednisone.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Anxiety, Brain natriuretic peptide, C-reactive protein, Computerised tomogram head
Clinical narrative: Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Electrocardiogram, Facial paralysis, Full blood count, Hypertension
Clinical narrative: Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Metabolic function test, Pulse abnormal, Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tachycardia, Urine analysis
Clinical narrative: Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Electrocardiogram
Clinical narrative: Patient's wife stated that patient had been feeling weak and dizzy prior to administration of vaccine.  During observation patient's wife informed medic that patient was feeling dizzy.  Patient was taken to medic area.  Vital signs as follows 63/49, pulse 112   O2 97%           BS 146.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: One week following injection, I experienced a rash on my upper left arm around the injection site.  This rash began small, and is now an oval about 4" by 2."  It is itchy and red.  This appears to be the only reaction, so far.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Feeling cold, Pain in extremity
Clinical narrative: Sore arm starting around 1300hrs.  Approximately 1830hrs, felt like I couldn't get warm, took temperature and was at 100.1.  Went to bed and then start with serious chills and uncontrollable shivering.  By 1930hrs, temperature was 102.2.  Took two Extra Strength Tylenol around 2000hrs, shivering stopped about 30 minutes later and I fell asleep.  Woke up the next morning feeling tired, but without fever.  Felt fine by the end of the day.
Sex: F
Vaccine: PPV
Symptoms: Delirium, Feeling abnormal, Peripheral swelling, Pyrexia
Clinical narrative: experienced deliria; left arm swelled up; experienced a fever; This spontaneous report was received from a 63-year-old female patient regarding herself. The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided. The patient's concurrent condition included immune system disorder and asthma.  On 28-SEP-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter in left arm (lot#, expiry date, strength, frequency were not reported) for prophylaxis. On an unknown date, the patient started therapy with mometasone furoate (ASMANEX TWISTHALER) (lot#, expiry date, strength, frequency and indication were not reported). On 28-SEP-2017 (also reported as later that evening), the patient's left arm swelled up (peripheral swelling), she experienced deliria (delirium) and fever (pyrexia). On an unknown date in 2017, symptoms caused the patient to get hospitalized for the 10 days. The patient felt like she was out of it. The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not available for retrieval. It was unable to arrange retrieval of mometasone furoate (ASMANEX TWISTHALER). Action taken with respect to mometasone furoate (ASMANEX TWISTHALER) was unknown. The outcome of peripheral swelling, delirium and pyrexia was reported as recovered. Causality assessment was not reported.  Upon internal review, the event of delirium was determined to be medically significant. combinationproductreport: Yes; brandname: ASMANEX TWISTHALER INHALER (DEVICE); commondevicename: mometasone furoate; productcode: KCO; devicetype: NASAL SPRAY, ENT DELIVERY (KCO); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: has hot erythema in a 3x3 inch patch at the site of injection /  it is red, hot and a little raised; has hot erythema in a 3x3 inch patch at the site of injection /  it is red, hot and a little raised; has hot erythema in a 3x3 inch patch at the site of injection /  it is red, hot and a little raised; fatigue; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth, fatigue and headache. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved and the outcome of the fatigue and headache were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix on right arm. On same night of vaccination, the patient had hot erythema in a 3x3 inch patch at the site of injection, it was red, hot and a little raised. The symptoms were ongoing at the time of reporting. The patient also had fatigue and headache. Fatigue and headache were resolving. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: the injection site is swollen; the injection site is / painful; area is red from the injection site down to the elbow/the injection site is / red; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number HD3K2, expiry date 7th May 2022) for prophylaxis.   On 9th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling, injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site swelling, injection site pain and erythema of extremities were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Shingrix in left arm. The patient experienced injection site swelling, redeness and pain. The pharmacist reported that the area was red from the injection site down to the elbow. The reporter gave consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site reaction
Clinical narrative: Subcutaneous injection over the left triceps; Area became red and devleoped an immune response; Area became red and devleoped an immune response; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a subcutaneous injection over the left triceps and the area became red and developed an immune response.  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 by subcutaneous injection in the left triceps prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient's injection site became red and developed an immune response which resolved in 24 hours. No treatment information was provided for the events.  Action taken with mRNA-1273 in response to the events was not provided.   The events, subcutaneous injection over the left triceps, was considered resolved on 05 Jan 2021. The events, area became red and developed an immune response, were considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown) and who experienced Subcutaneous injection over the left triceps with and associated non-serious and expected event of Area became red and developed an immune response. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a nurse concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.   On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 62-year old female patient who received their first of two planned doses of mRNA-1273 (Lot number: 027L20A), from a vial that had reached room temperature.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # 027L20A. There were no reported AEs associated with this case of product storage error.; Sender's Comments:  MOD-2021-003111: MOD-2021-003090: MOD-2021-003082:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a nurse practitioner concerning a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.   On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 67-year-old, male patient, who experienced an unexpected event of vaccine administered after they lost temperature.  This report refers to a case of out of specification product use for mRNA-1273 (Lot number: 027L20A). There were no reported AEs associated with this case of out of specification product use.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Device temperature issue, Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a nurse concerning a White, 70-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, 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, lot # 027L20A. There were no reported AEs associated with this case of out of specification product use.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report  was received from a healthcare facility staff member concerning a White, 76-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, experienced vaccine administered after vaccine lost temperature, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of a 76-year-old male patient who experienced non-serious of after the vaccines lost temperature they were administered. (Out of specification product use) for mRNA-1273, lot # 027L20A), Exp date-unknown. There were no reported AEs associated with this case of Incomplete dose administered
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: After the vaccines lost temperature they were administered; A spontaneous report was received from a nurse practitioner concerning a 70-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.   On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 70-year-old, male patient, who experienced an unexpected event of vaccine administered after they lost temperature.  This report refers to a case of out of specification product use for mRNA-1273 (Lot number: 027L20A). There were no reported AEs associated with this case of out of specification product use.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Received the 1st dose of Moderna vaccine subcutaneously; A spontaneous report was received from a HCP concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced the 1st dose of Moderna vaccine subcutaneously.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 on an unknown date subcutaneously for prophylaxis of COVID-19 infection.   On an unknown date, a patient received the 1st dose of Moderna vaccine subcutaneously. Treatment for the event was not provided.    Action taken with mRNA-1273 in response to the event was not provided.   The event, received the 1st dose of Moderna vaccine subcutaneously, were considered resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration error for mRNA-1273. There were no reported AEs associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years old patient received 1st dose of moderna vaccine; A spontaneous report was received from a physician concerning a 16-year-old patient who was participating in the mRNA-1273 Emergency Use Program and they gave first dose to a patient 16-years-old.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 07-Jan-2021 intramuscularly for prophylaxis of COVID-19 infection.   The reporter reported that the patient received the Moderna vaccine on 07-Jan-2021. He stated that the patient was 16-years-old. No adverse reactions were reported.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event they gave first dose to a patient 16-years-old was considered resolved on 07-Jan-2021.    The reporter did not provide a causality assessment for the event they gave first dose to a patient 16-years-old.; Reporter's Comments: This report refers to a case of 16- year-old patient who experienced non-serious unexpected event of first dose to a patient 16-years-old (product administered to patient of inappropriate age) for mRNA-1273, lot # unknown, Exp date-unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: While receiving the injection something dribbled down her arm.She thinks she did not receive the dose in it's entirety; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program  and while receiving the injection something dribbled down her arm.. She thinks she did not receive the dose in it's entirety[Incorrect dose administered].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 09-Jan-2021, immediately prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot # 011L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   During the administration of the vaccine, the patient reported that she felt something dribble down her arm and she believes she did not receive the dose in its entirety. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event was not reported.; Reporter's Comments: This report refers to a case of 73- year-old female patient who experienced non-serious unexpected event of vaccine  she felt something dribble down her arm and she believes she did not receive the dose in its entirety(Incomplete dose administered) for mRNA-1273, lot # 011L20A), Exp date-unknown. There were no reported AEs associated with this case of Incomplete dose administered.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old volunteer was vaccinated; A spontaneous report was received from a physician concerning a 16-year-old male patient (also reported as 15 year old volunteer) who was participating in the mRNA-1273 Emergency Use Program and was vaccinated.   The patient's medical history was not provided. No concomitant medications were provided.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 in his right deltoid for prophylaxis of COVID-19 infection and the mother is upset. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event inappropriate age at vaccine administration was resolved on 10 Jan 2021.  The reporter did not provide an assessment for the event.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.