chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Received a partial dose during their second dose of Moderna; the needle coming off during administration; A spontaneous report was received from a healthcare professional concerning a 76-year-old female patient, who received a partial dose during her second dose of Moderna vaccine administration / MedDRA PT: underdose due to the needle coming off during administration /MedDRA PT: device connection issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Lot number not provided) on an unknown date. On 07-Feb-2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of Covid-19 infection.  It was reported that a female patient did not get the full dose of the Moderna vaccine due to the needle coming off during administration. No further information was provided. Treatment information was unknown. Consent given to follow-up.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, received a partial dose during her second dose of Moderna vaccine due to the needle coming off during administration, were considered resolved.; Reporter's Comments: This report refers to a case of underdose and syringe issue for mRNA (lot # unknown) with no reported AEs in the second dose.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Syringe Leaked (Suboptimal Dose administered); Syringe Leaked (Suboptimal Dose administered); A spontaneous report was received from a physician concerning a patient of unknown/undisclosed age and gender who experienced syringe leak (Suboptimal Dose Administered) and underdose   The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.       On 3FEB2021, the patient received one of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   Female Physician called to report that while mass-vaccinating with the Moderna COVID-19 vaccine on 3FEB2021, the syringe leaked on two cases. She reported the needle was not properly attached to the barrel. As a result, two patients possibly did not receive the full dose of the Vaccine.   Action taken with mRNA-1273 in response to the events was not provided.  The events, syringe leak (Suboptimal Dose Administered) and underdose, was considered recovered/resolved or recovered/resolved.; Reporter's Comments: This report refers to a case of underdose and syringe issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site lymphadenopathy, Injection site pain, Muscle tightness, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: Unsure if shot was administered intramuscularly in the deltoid; Muscles on the whole right side of her body are flaring up and tensing up; The big gland in her axillary area are really big; Scapula and shoulder blade area was very tense and balling up; Arm was sore; A regulatory authority report was received from a healthcare professional concerning a 37-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced unsure if shot was administered intramuscularly in the deltoid, muscles on the whole right side of her body are flaring up and tensing up, arm was sore, the big gland in her axillary area are really big and her scapula and shoulder blade area was very tense and balling up.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 15 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot 025L20A) intramuscularly in the right, dominant arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient received first shot in right, dominant arm at the peak of shoulder, between the clavicle and humerus and is unsure if shot was administered intramuscularly in the deltoid. She reported the muscles on the whole right side of her body flared and tensed up, arm was sore, the big gland in her axillary area was really big and her scapula and shoulder blade area was very tense and balling up. Treatment for the event included paracetamol, diphenhydramine citrate, and ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The event, unsure if shot was administered intramuscularly in the deltoid, was considered resolved on 15 Jan 2021. The outcomes of the events, muscles on the whole right side of her body are flaring up and tensing up, arm was sore, the big gland in her axillary area are really big and her scapula and shoulder blade area was very tense and balling up, were unknown.; Reporter's Comments: This report refers to a 37 Y/O female who had NS event Product administered at inappropriate site with NS unexpected Muscle tightness, Musculoskeletal stiffness, and NS expected Injection site lymphadenopathy, Injection site pain. Event onset the same day as first dose mRNA-1273. Treated with paracetamol, diphenhydramine, ibuprofen. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received both doses of the Moderna Covid-19 vaccine 2 weeks apart not 1 month.; A spontaneous report was received from a consumer concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced receiving both doses 2 weeks apart/inappropriate schedule of vaccine administration.   The patient's medical history is not provided by the reporter. Concomitant medications were not reported.   The patient received their first and second of two planned dose of mRNA-1273 on an unknown date (Lot number: unknown). Per the patient, a second dose was received 2 weeks after the first, not 1 month.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of event is unknown.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Did not receive full dose; Fell drops on their arms; A spontaneous report was received from a Healthcare Professional concerning a patient who was administered Moderna's COVID-19 vaccine and did not receive full dose.  The patient medical history was not included. Patient concomitant was not included  On 07-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) prophylaxis of COVID-19 infection.  Caller states there were 2 patients that received the vaccine on 07-feb-2021. The needles were not attached completely and they did not receive the full dose. The patients fell drops on their arms. She reported this through VAERS. She wants to know if she should repeat the shot or continue.   Treatment of these event (s) were not provided.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered "10 cc"; A spontaneous report was received from a healthcare professional concerning a 63-year-old female patient who stated that after her injection she asked the nurse what dose she received and the nurse stated she administered "10 cc"/accidental overdose.   The patient's medical history included allergy to hydromorphone hydrochloride (has severe vomiting), diabetes and hypertension.    Products known to have been used by the patient included insulin detemir, insulin aspart, carvedilol, and losartan.   On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  After the injection, the consumer asked the nurse what dose she received, and the consumer reported that the nurse stated she was administered "10 cc". The consumer stated she was going to call the vaccination site back to verify what dose she was given. She reported that she isn't experiencing any adverse events or side effects after the vaccination.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event was not reported.; Reporter's Comments: This case concerns a 68-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 039K20A), reporting accidental overdose without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Underdose
Clinical narrative: nurse mistakenly administered 0.1ml of the vaccine to 8 patients; gave the remaining dose of the vaccine; A spontaneous report was received from a physician concerning eight patients who received Moderna's COVID-19 vaccine (mRNA-1273 and were mistakenly administered 0.1ml of the vaccine, returned and rest of the full dose was administered.  Medical history for patients was not provided, nor were any concomitant medications.  On an unspecified date, a nurse in a physician's office administered the incorrect dose of mRNA-1273 for prophylaxis of COVID-19 infection to eight patients. Lot number was not reported. Injection site not provided.  Seven of the eight patients came back to have the rest of the full dose administered. Physician wanted to know if this was the correct course of action.  No other actions taken with mRNA-1273 were reported.   Outcome for this event, eight patients receiving the incorrect dose of the vaccine was considered resolved.; Reporter's Comments: This is a case of vaccine exposure in a patient of unknown age and gender who was mistakenly administered 0.1ml of the vaccine (vaccine underdose) and rest of the full dose was administered (extra dose administered) for mRNA-1273 vaccine Lot # unknown. There was no associated adverse event reported  for the events of underdose and extra dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021); A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient was administered the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021).   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 22 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 on 09 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection.   HCP (healthcare professional) reported that a patient was administered with the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021). No further information was reported.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the event was unknown.  The reporter did not provide an assessment for the event, patient was administered the second dose of the Moderna COVID-19 vaccine today (09 Feb 2021) seventeen days from the first dose (22 Jan 2021).; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years of age, received the first dose; A spontaneous report  was received from a Pharmacist concerning a 16-year-old, female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273), resulting in the event, 16 years of age, received the first dose/product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09 Feb 2021, the patient received their first of two planned of mRNA-1273 (Lot number: 011M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection  Pharmacist called in 09-FEB-2021 to report giving first dose of mRNA-1273 to a female patient 16 years of age. The pharmacist inquired if the dose regimen should be discontinued or completed with the second dose when due. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, 16 years of age, received the first dose, was considered resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 011M20A with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Instead of the injection being injected into the delta muscle, he received it in teh bursa area of his shoulder; A spontaneous report was received from a consumer concerning a male patient who received an Moderna vaccine injection into the wrong body part (bursa).  The patients medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 01-FEB-2021 in the bursa area of his shoulder for prophylaxis of COVID-19 infection.  Instead of the injection being injected into the delta muscle, the patient received it in the bursa area of his shoulder.   Treatment information was not provided/unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event was considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: COVID arm  reaction, was diagnosed as cellulitis; A spontaneous report was received from a healthcare professional concerning a female patient who developed "covid arm" reaction, diagnosed as cellulitis/PT: cellulitis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received dose of mRNA-1273 (Lot #, route of administration, and injection site unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient had "covid arm" reaction, went to the emergency room (ER) and was diagnosed as cellulitis and treated that way.   Treatment details were unknown.  Action taken with mRNA-1273 was not provided.  The outcome of event "covid arm" reaction, diagnosed as cellulitis was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced a serious unexpected event of cellulitis in the arm occurring with unknown latency after the first dose of mRNA-1273. Treatment for cellulitis. Outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: accidentally administered 1mL instead of the standard 0.5mL; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) was given twice the amount of the vaccine.    The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 09 Feb 2021, the patient received accidentally administered 1mL instead of the standard 0.5mL dose to a patient. The pharmacist was not in the office and did not have access to the Patient Information or Medical Information. Pharmacist is inquiring about the most common side effects reported with the Moderna COVID19 Vaccine. Pharmacist would like to receive information via email.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided  The event gave twice the amount of the vaccine was considered resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, and overdose for mRNA-1273 with no associated AEs.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Atrial fibrillation, Chills, Injection site erythema, Injection site pruritus
Clinical narrative: Lots of bloating; Not feeling good; Arm got really sore; Afib; Lots of chills; Redness itching at the injection site; Itching at the injection site; A spontaneous report was received from a consumer who is a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed atrial fibrillation, arm got really sore, redness itching at the injection site, lots of bloating, lots of chills and just not feeling good,  The patient's medical history included tachycardia, COVID-19, atrial fibrillation, asthma and lung inflammation. Products known to have been used by the patient, within two weeks prior to the event, included diltiazem, flecainide and rivaroxaban.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, at noon, post vaccination, the patient reported she had atrial fibrillation. She was able to get it under control until it started back again at approximately 4 pm the same day. At 6 pm that evening, the patient reported her arm was really sore, there was redness and itching at the injection site. She had lots of bloating, chills and overall, not feeling good. The patient stated it felt like having COVID again.   Treatment for the event included hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, afib/atrial fibrillation, was considered not resolved.   The outcome of the events arm got really sore, redness itching at the injection site, lots of bloating, lots of chills, just not feeling good, and feeling like having COVID all over again were considered unknown.  Follow-up received on 16 Feb 2021 included date of when patient had COVID-19, treatment information and added redness and itching at the injection site to the events.; Reporter's Comments: Based on the current available information, which includes a strong temporal association with onset of the reported events and the use of the product, a causal association cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Lots of bloating; Not feeling good; Arm got really sore; Afib; Lots of chills; Redness itching at the injection site; Itching at the injection site; A spontaneous report was received from a consumer who is a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed atrial fibrillation, arm got really sore, redness itching at the injection site, lots of bloating, lots of chills and just not feeling good,  The patient's medical history included tachycardia, COVID-19, atrial fibrillation, asthma and lung inflammation. Products known to have been used by the patient, within two weeks prior to the event, included diltiazem, flecainide and rivaroxaban.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, at noon, post vaccination, the patient reported she had atrial fibrillation. She was able to get it under control until it started back again at approximately 4 pm the same day. At 6 pm that evening, the patient reported her arm was really sore, there was redness and itching at the injection site. She had lots of bloating, chills and overall, not feeling good. The patient stated it felt like having COVID again.   Treatment for the event included hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, afib/atrial fibrillation, was considered not resolved.   The outcome of the events arm got really sore, redness itching at the injection site, lots of bloating, lots of chills, just not feeling good, and feeling like having COVID all over again were considered unknown.  Follow-up received on 16 Feb 2021 included date of when patient had COVID-19, treatment information and added redness and itching at the injection site to the events.; Reporter's Comments: Based on the current available information, which includes a strong temporal association with onset of the reported events and the use of the product, a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Deviation from time-frame: second shot on the 42 day; A spontaneous report was received from a Reporter like HCP concerning a 53 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate schedule of vaccine administration.    The patient had an emergency dental procedure because root canal was not done properly. Concomitant medications included cymbalta 30 mg and bystolic 5 mg. The patient is on antibiotics and steroids.   On Date 31-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the Left arm for prophylaxis of COVID-19 infection and on 09-FEB-2021 patient received second of two planned doses in right arm (lot/ batch: Not provided).   On 9-FEB-2021, the patient experienced her second shot on the 42nd  day after the first vaccine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event "deviation from time-frame: second shot on the 42 day" was considered resolved on 09-FEB-2021.; Reporter's Comments: This case concerns 53 year old female patient who received second of two planned doses in right arm (lot/ batch: Not provided) 42 days after the first dose. No reported adverse events after the vaccine was administered in this case of inappropriate schedule of product administration.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Oedema mouth
Clinical narrative: Angioedema; Swelling around surgical clips in her mouth; A spontaneous report was received from a health care professional concerning a female patient (age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema and swelling around surgical clips in her mouth.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received one of two planned doses (first or second dose not specified) of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced angioedema and swelling around surgical clips in her mouth. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, angioedema and swelling around surgical clips in her mouth, was not reported.; Reporter's Comments: This case concerns a female of unknown age who had a serious unexpected event of angioedema and a nonserious unexpected event of mouth edema. The events occurred with unknown latency after both the first dose of mRNA-1273. Treatment information not reported. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was retrieved on 01-Feb-2021 reported by other health professional and concerned a 35-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 27-Nov-2018, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: left arm, route of administration, dose and indication: not reported). The batch number reported was YF42409.   On the same day, after receiving Afluria Quadrivalent, the patient experienced rash.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.   This case was assessed as non-serious.  Company comment: The event of 'rash' is assessed as related to Afluria Quadrivalent.; Sender's Comments: The event of 'rash' is assessed as related to Afluria Quadrivalent.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Hypoaesthesia oral, Rhinorrhoea
Clinical narrative: Secretions from eyes and nose; Numbness in mouth and lips; Secretions from eyes and nose; This spontaneous case was received on 02-Feb-2021 from other non-health professional via Med Communications (reference number: SEQW21-00380) and concerned a 57-year-old, female patient.  The patient's concurrent condition included unspecified problems with her thyroid. The patient's concomitant medication included levothyroxine for unreported indication.  On 06-Oct-2015, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location, indication and route of administration: not reported). The batch number was not reported.  On an unspecified date, unknown amount of time after receiving Afluria Quadrivalent, the patient had secretions from eyes and nose for several hours and numbness in mouth and lips.  On an unspecified date, the patient recovered from the events 'nasal discharge' and 'discharge eye'.  The outcome of the event 'numbness oral' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company Comment: A 57-year-old, female patient developed eye discharge, hypoaesthesia oral and rhinorrhoea after vaccination with the suspect product, Afluria Quadrivalent. There is lack of information regarding the vaccination date and events onset date. Therefore, chronology is unassessable. More information regarding the underlying medical history is needed. Information regarding the related diagnostic findings have not been provided. Due to lack of information, causality for the reported events is unassessable.; Sender's Comments: A 57-year-old, female patient developed eye discharge, hypoaesthesia oral and rhinorrhoea after vaccination with the suspect product, Afluria Quadrivalent. There is lack of information regarding the vaccination date and events onset date. Therefore, chronology is unassessable. More information regarding the underlying medical history is needed. Information regarding the related diagnostic findings have not been provided. Due to lack of information, causality for the reported events is unassessable.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Impaired work ability, Oropharyngeal pain, Swelling face
Clinical narrative: Felt like razor blades in the throat; Facial swelling of eyes; Had an allergic reaction; This spontaneous case from the United States was received on 04-Feb-2021 reported by other non-health care professional (consumer) via Med Communications (reference number: SEQW21-00404) and concerned a 56-year-old, female patient.  The patient had no relevant medical history. The patient's concomitant medications included metoprolol, Baby aspirin (acetylsalicylic acid), Zetia (ezetimibe) and Crestor (rosuvastatin calcium), all for an unreported indication.  On an unspecified date in Jan-2018, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, route of administration, anatomical location, dose, batch number and expiration date: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in Jan-2018, during the night after receiving Afluria Quadrivalent, the patient experienced an allergic reaction, facial swelling of eyes and felt like razor blades in the throat. The patient missed work the next day due to reaction and was clear the following day to return to work. The patient did not receive any treatment.  On an unspecifed date, the patient recovered from the events.   The reporter did not provide causality assessment.  Company comment: A 56-year-old patient was administered Afluria Quadrivalent. During the night after receiving Afluria Quadrivalent, the patient experienced an allergic reaction, facial swelling of eyes and felt like razor blades in the throat. The patient missed work the next day due to reaction and was clear the following day to return to work. The patient did not receive any treatment. Chronology is plausible. Causal role of the suspect vaccine is assessed as possibly related for eye swelling, oropharyngeal discomfort and hypersensitivity.; Sender's Comments: A 56-year-old patient was administered Afluria Quadrivalent. During the night after receiving Afluria Quadrivalent, the patient experienced an allergic reaction, facial swelling of eyes and felt like razor blades in the throat. The patient missed work the next day due to reaction and was clear the following day to return to work. The patient did not receive any treatment. Chronology is plausible. Causal role of the suspect vaccine is assessed as possibly related for eye swelling, oropharyngeal discomfort and hypersensitivity.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache began the evening after receiving the vaccine by the next day, headache pain more than a 10. After consulting dr who told her  to take Tylenol.  Tylenol has brought the pain level to about 7, 2 weeks later.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: Finger nodule on the right hand, ring finger.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: 2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, very tired/fatigue, moderate to severe upper body muscle aches, mild migratory chest pains for about 30 minutes. 24 hrs after injection just overwhelming fatigue& mild headache continued for another 12 hrs. 48 hrs. After injection  symptoms gone.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: PAIN, HEADACHE, AND FEVER
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Limb discomfort, Nausea, Pain in extremity
Clinical narrative: Red, itchy rash on arm 2 days after injection Very sore arm 1 day after injection and slightly swollen arm at injection site   A feeling of heaviness in the arm  Some Nausea  3 days after injection
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Red, itchy rash on arm 2 days after injection Very sore arm 1 day after injection and slightly swollen arm at injection site   A feeling of heaviness in the arm  Some Nausea  3 days after injection
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Started with a fever that slowly worsened to a high temperature. This resulted in chills, aches, pains, fatigue. nausea, congestion, sore throat,  headaches, and weakness. There was also swelling at the injection site and  swelling of my eyelids.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Started with a fever that slowly worsened to a high temperature. This resulted in chills, aches, pains, fatigue. nausea, congestion, sore throat,  headaches, and weakness. There was also swelling at the injection site and  swelling of my eyelids.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Swelling of eyelid
Clinical narrative: Started with a fever that slowly worsened to a high temperature. This resulted in chills, aches, pains, fatigue. nausea, congestion, sore throat,  headaches, and weakness. There was also swelling at the injection site and  swelling of my eyelids.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Irritability, Pain in extremity, Poor feeding infant, Screaming
Clinical narrative: Immunizations given at 12:06 pm. Child slept until approximately 3:30 pm after feeding. Gave tylenol when had the immunizations and again when awoke crying. Poor po intake during this time and vomited. Fed better the next morning, still irritable for the next 2 days. Mother reported after the 2 month visit, baby took a nap then awoke screaming. He was not consolable for 3 hours. His leg seemed sore to touch. He ate less that day. Acetaminophen did not alter cry or inconsolably. He went to sleep and woke the next day and returned to improved eating. There were no concurrent illnesses. Mom did not call the office after the 2 month visit, but did bring this up just prior to the 4 month shots at the office. Six days
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Somnolence, Vomiting
Clinical narrative: Immunizations given at 12:06 pm. Child slept until approximately 3:30 pm after feeding. Gave tylenol when had the immunizations and again when awoke crying. Poor po intake during this time and vomited. Fed better the next morning, still irritable for the next 2 days. Mother reported after the 2 month visit, baby took a nap then awoke screaming. He was not consolable for 3 hours. His leg seemed sore to touch. He ate less that day. Acetaminophen did not alter cry or inconsolably. He went to sleep and woke the next day and returned to improved eating. There were no concurrent illnesses. Mom did not call the office after the 2 month visit, but did bring this up just prior to the 4 month shots at the office. Six days
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough
Clinical narrative: Develope a cough with chest pain
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Complaints of nausea, vomiting and chills. In the Emergency room. Had to have IV Zofran, promethazine, and Normal Saline Bolus.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling drunk, Hypoaesthesia, Joint stiffness
Clinical narrative: after 1 hour feeling light headed, felt drunk for 7 hours, elbow stiffness on right arm, numbing feeling on right arm, fingertips numbness
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Chills, Erythema, Lymphadenopathy, Pain
Clinical narrative: Moderna COVID-19 Vaccine EUA 14 hrs after dose 2, fever, chills, aches, 20 min AFIB.  Back to sinus rhythm after 20 min on its own.  14 hrs after adverse effect started, fever normal, aches gone.  Arm red, somewhat swollen.  6 hrs later, arm redder from injection site entire front of biceps down to elbow.  Lump at bottom of biceps and enraged lymph node in armpit.  25 hours after noticing COVID arm, swelling down, lump on bicep gone and redness subsiding. Feeling good
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA 14 hrs after dose 2, fever, chills, aches, 20 min AFIB.  Back to sinus rhythm after 20 min on its own.  14 hrs after adverse effect started, fever normal, aches gone.  Arm red, somewhat swollen.  6 hrs later, arm redder from injection site entire front of biceps down to elbow.  Lump at bottom of biceps and enraged lymph node in armpit.  25 hours after noticing COVID arm, swelling down, lump on bicep gone and redness subsiding. Feeling good
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and palpable swelling and injection site
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Headache, Myalgia
Clinical narrative: Temperature, Short of breath, congestion, dizzy, muscle pain,Headache
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Temperature, Short of breath, congestion, dizzy, muscle pain,Headache
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Loss of consciousness, Pyrexia, Syncope
Clinical narrative: High Fever, 103 for 48 hours, syncope, passed out twice during the first 24 hours.  Severe back pain.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Feeling hot, Headache, Influenza like illness
Clinical narrative: I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain
Clinical narrative: I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Feeling hot, Inflammation, Swelling, Urticaria
Clinical narrative: On the 19th I started getting a welt on it. it spread, got inflamed and swollen. It was hot to the touch. Dr. said I had cellulitis. prescribed antibiotics.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea
Clinical narrative: CHILLS, NAUSEA, DIZZINESS, AND HEADACHE.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Computerised tomogram, Electrocardiogram normal, Fibrin D dimer normal, Full blood count normal
Clinical narrative: sudden onset pain left armpit radiating down to elbow and into left breast and back.   Severe.  Treated at ER with percoset and turadol and aspirin.  Tested for blood clots, heart attack, lymph node anomaly.   Everything tested came back as normal.  Sent home.  Used naproxen and hydrocodone and ice at home.  discomfort continues but is bearable now (next day) with drugs and ice.    Note:  Took monthly Cosentyx shot on Feb 20, 2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Pain, Troponin normal, Ultrasound scan normal
Clinical narrative: sudden onset pain left armpit radiating down to elbow and into left breast and back.   Severe.  Treated at ER with percoset and turadol and aspirin.  Tested for blood clots, heart attack, lymph node anomaly.   Everything tested came back as normal.  Sent home.  Used naproxen and hydrocodone and ice at home.  discomfort continues but is bearable now (next day) with drugs and ice.    Note:  Took monthly Cosentyx shot on Feb 20, 2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Nausea
Clinical narrative: Abdominal cramps and loose bowels; nausea, and chills
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hot flush, Hyperhidrosis
Clinical narrative: Alternating chills and hot flashes/sweats. Just let it run its course.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Spinal pain
Clinical narrative: Pt. in for a second dose of Covid Vaccine, Moderna, arrived in observation unit with c/o pain in the spine and tightness in the chest w/o s/s of sob, nausea, vomiting. Pt. states did not have any occurences with the first vaccine. Patient was transported to higher level of care via W/C in no acute distress.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Axillary pain, Pain
Clinical narrative: Child developed shoulder and axilla pain with radiation down arm soon after receiving vaccine.  Office was notified on 2/15/2021 (6 days following vaccine)  that pain was still present. Child was examined via a telehealth visit on 2/ 16/2021 (7 days following vaccine).  Could have been considered a neuritis based on presentation, but could also have been related to vaccine administration.  Attempted to follow up today, 2/23/2021, unable to reach mother.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Nausea, Pain
Clinical narrative: 3 pregnancies (last in 2000). Moderna vaccine.  Chest rash started and has progressively moved from chest to back/neck over the past week. Woke up today and it is on  my left arm (faintly). Concerned because I am due for #2 on Friday, 2/26.  Also - I had Covid 19 infection on 10/30/2020. I had mild fever, body aches, lost taste/smell for 1.5 months, and had vertido N/V on Day #10. Nop coiugh but congestion for 2 days. Full recovery.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Respiratory tract congestion, SARS-CoV-2 antibody test negative, Vertigo
Clinical narrative: 3 pregnancies (last in 2000). Moderna vaccine.  Chest rash started and has progressively moved from chest to back/neck over the past week. Woke up today and it is on  my left arm (faintly). Concerned because I am due for #2 on Friday, 2/26.  Also - I had Covid 19 infection on 10/30/2020. I had mild fever, body aches, lost taste/smell for 1.5 months, and had vertido N/V on Day #10. Nop coiugh but congestion for 2 days. Full recovery.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 3 pregnancies (last in 2000). Moderna vaccine.  Chest rash started and has progressively moved from chest to back/neck over the past week. Woke up today and it is on  my left arm (faintly). Concerned because I am due for #2 on Friday, 2/26.  Also - I had Covid 19 infection on 10/30/2020. I had mild fever, body aches, lost taste/smell for 1.5 months, and had vertido N/V on Day #10. Nop coiugh but congestion for 2 days. Full recovery.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Injection site rash, Rash
Clinical narrative: Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives on face and behind ears and some on shoulders and arms client took Benadryl by pm the face was red without hive and by Sunday the Hives had disappeared.  Monday redness on face and by Tuesday all hives had resolved.  Tuesday still very weak and fatigued and if sits upright HR increases, eating and drinking without interruption.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives on face and behind ears and some on shoulders and arms client took Benadryl by pm the face was red without hive and by Sunday the Hives had disappeared.  Monday redness on face and by Tuesday all hives had resolved.  Tuesday still very weak and fatigued and if sits upright HR increases, eating and drinking without interruption.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Red stripe on arm, approximately 4" long and 2" wide, showed up sometime between 2/22/21 (not noticed after morning shower) and 2/23/21 7:30am (noticed after morning shower). Smooth and not hot to touch. Slightly itchy.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe joint pain in left hand.  Treated with CBD oil and exercise.  Severe pain subsided within two hours.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness
Clinical narrative: pt c/o dizziness and feeling weak in the legs approximately 15 post vaccination. On scene provider notified. Pt notified to be observed for an additional 15 mins. Pt stated felt fine after second observation period. No further action needed.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pain
Clinical narrative: Fever, chills, nausea, aching joints and body, headache, burning prickly skin
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Skin burning sensation
Clinical narrative: Fever, chills, nausea, aching joints and body, headache, burning prickly skin
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: pt stated that  went to bed w/ a sore are the night after receiving the covid vax.  She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache.  She felt like she had fever but she said it was only 99.  Her left arm was swollen, red  and hot around the injection site.   Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: pt stated that  went to bed w/ a sore are the night after receiving the covid vax.  She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache.  She felt like she had fever but she said it was only 99.  Her left arm was swollen, red  and hot around the injection site.   Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: pt stated that  went to bed w/ a sore are the night after receiving the covid vax.  She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache.  She felt like she had fever but she said it was only 99.  Her left arm was swollen, red  and hot around the injection site.   Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Essential tremor, Muscle spasms, Pain in extremity, Thyroid function test
Clinical narrative: pt stated that  went to bed w/ a sore are the night after receiving the covid vax.  She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache.  She felt like she had fever but she said it was only 99.  Her left arm was swollen, red  and hot around the injection site.   Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain, Balance disorder, Body temperature fluctuation, Feeling cold
Clinical narrative: pt stated that  went to bed w/ a sore are the night after receiving the covid vax.  She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache.  She felt like she had fever but she said it was only 99.  Her left arm was swollen, red  and hot around the injection site.   Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.