chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Oral mucosal blistering, Pain, Pain in extremity
Clinical narrative: blisters in mouth and numbness on left side of face chills aches sore arm
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Face and mouth X-ray, Tinnitus
Clinical narrative: I have been experiencing pulsatile tinnitus in my ears since having the injection for 2+ weeks now.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Nasal congestion, Nausea
Clinical narrative: Fatigue, nausea, muscle soreness, stuffy nose, dizziness, achy
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Fatigue, nausea, muscle soreness, stuffy nose, dizziness, achy
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Allergy test, Dysphagia, Eye irritation, Flushing
Clinical narrative: Experienced a delayed reaction to vaccine that occurred at 11 p. m.  Administration was at 8:23 a. m. earlier in the day.  Symptoms began as build up of mucous in back of throat and reflux. Very early the next morning symptoms progressed to near inability to swallow,    Took 50 mg of Benadryl which gave a bit of relief.  Very hard to drink the water and get it down with the two pills.  The symptoms included swollen lips and inside of the mouth swelling.  Went to the emergency room at the Clinic  at 7:30 a. m.   I was given 60 mg of Prednisone, Pepsid to coat the stomach re the steroids. Was sent home with prescription for epi pen, medrol dose pack, Pepsid and Zyrtec.  Symptoms improved except for swelling of lips.  However, on 3/11/21, despite taking the medication, the symptoms worsened in terms of renewed lip swell as well as new symptoms of facial flushing and chest flushing.  Symptoms then abated with medication.  On 3/13/21, symptoms flared again with renewed lip swelling, inside and outside check swelling and outside face and chest flushing.  They they abated again with medication.  On 3/14/21, lip swelling renewed as a symptom.  To date, my lips do not feel right but tingly and bloated and irritated.  Saw an allergist this morning who thinks I am allergic to polyglycol a preservative in the vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Lip swelling, Mouth swelling, Paraesthesia oral, Secretion discharge
Clinical narrative: Experienced a delayed reaction to vaccine that occurred at 11 p. m.  Administration was at 8:23 a. m. earlier in the day.  Symptoms began as build up of mucous in back of throat and reflux. Very early the next morning symptoms progressed to near inability to swallow,    Took 50 mg of Benadryl which gave a bit of relief.  Very hard to drink the water and get it down with the two pills.  The symptoms included swollen lips and inside of the mouth swelling.  Went to the emergency room at the Clinic  at 7:30 a. m.   I was given 60 mg of Prednisone, Pepsid to coat the stomach re the steroids. Was sent home with prescription for epi pen, medrol dose pack, Pepsid and Zyrtec.  Symptoms improved except for swelling of lips.  However, on 3/11/21, despite taking the medication, the symptoms worsened in terms of renewed lip swell as well as new symptoms of facial flushing and chest flushing.  Symptoms then abated with medication.  On 3/13/21, symptoms flared again with renewed lip swelling, inside and outside check swelling and outside face and chest flushing.  They they abated again with medication.  On 3/14/21, lip swelling renewed as a symptom.  To date, my lips do not feel right but tingly and bloated and irritated.  Saw an allergist this morning who thinks I am allergic to polyglycol a preservative in the vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: After 9 days I developed redness, warmth, pain and itching at injection sight.  followed by fatigue, heaviness, weakness in legs, chills and nausea.  Felt flu  like symptoms from about 3 days.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth, Limb discomfort, Muscular weakness, Nausea
Clinical narrative: After 9 days I developed redness, warmth, pain and itching at injection sight.  followed by fatigue, heaviness, weakness in legs, chills and nausea.  Felt flu  like symptoms from about 3 days.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Echocardiogram, Electrocardiogram, Hemiparesis, Hypoaesthesia
Clinical narrative: Patient woke up the morning following vaccine administration with numbness and weakness of his right arm and hand.  He later woke up from a nap that afternoon with numbness and weakness also in his right leg.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Patient woke up the morning following vaccine administration with numbness and weakness of his right arm and hand.  He later woke up from a nap that afternoon with numbness and weakness also in his right leg.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Pyrexia, SARS-CoV-2 test negative, Tremor
Clinical narrative: I received the second COVID vaccine (Pfizer-BioNTech) on 2/14/21. Within 12 hours of the vaccine, "normal" reaction symptoms occurred including fever, chills, sweating and rigors, which was a shaking feeling in the legs, arms, torso and other areas of the body. These symptoms lasted 1.5 days and then seemed to disappear, only to appear again in waves over 10 days following the second vaccine. On day 10, I had a fever of 101.4.  By 2 weeks out, most of the symptoms had dissipated aside from an internal shaking feeling which moves from the chest to the torso, legs etc. It's different all the time and but muscles are felt vibrating in the body and nearly 1 month later the vibrating symptoms are still present. The vibrating can be described like having an electric toothbrush inside your body.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Influenza, Pruritus
Clinical narrative: HR feels faster starting on march 7th, described as fluttery multiple times per day pruritis for  3 weeks after the first one. put on claritin.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Injection site extravasation, Product administered at inappropriate site
Clinical narrative: During my 2 covid injection, vaccine appeared to leak out from injection site. The person who administered used two cotton swabs wipe up leakage. The vaccine injection site did not appeared to be entered into the deltoid muscle. It looks to be too low and forward on my arm. I have a big bruise on my arm.  This not like the first shot. I do not feel any pain on my arm  from this shot, which is contrary to what most folks have said about the second shot.  I do not believe I received adequate amount of the vaccine and am not sure of my protection.  I do not know what to do or expect now.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: did not report any adverse events or issues; received an expired dose of GARD ASIL 9; This spontaneous report as received from a vaccine administrator referring to a 25-year-old female patient. The patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported.    On 12-FEB-2021 at approximately 16:00, the patient was vaccinated with expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # R005341, expiration date reported as 31-DEC-2020 (conflicting, also reported as 31-DEC-2021), however upon internal validation established as 06-DEC-2020 and formulation vial; strength, dose and route were not reported) in the right arm accidentally for prophylaxis (expired product administered). It was also reported that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) did not experience any temperature excursion. The patient left the facility and did not complain of any adverse events or any issues (no adverse event). The reporter stated that the patient was scheduled to receive a COVID vaccination on 13-FEB-2021.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No additional adverse events reported; the administration of expired VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 02-MAR-2021 the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) lot # S036494 with expiration date on 09-JAN-2021 (exact dose, route of administration were unknown) for prophylaxis. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: No further AE reported.; patient received his first dose of MMR II today (Mar 5, 2021) at age 5; This spontaneous report was received from a registered nurse and refers to a 5-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-MAR-2021, the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered). No adverse event was reported.
Sex: M
Vaccine: HPV9, MEN, UNK
Symptoms: Guillain-Barre syndrome
Clinical narrative: within 3 to 5 months was diagnosed with Guillain-Barre syndrome. The patient experienced effects that resulted in physical therapy and additional follow-ups for diagnosis; This spontaneous report was received from a consumer via a company representative, referring to a 11-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient received "all three adolescent vaccines" including hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis, meningococcal vaccine (unspecified) (manufacturer unknown) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) (strengths, anatomical sites of injection, routes of administration, lot numbers and expiration dates were not reported).  On an unknown date (reported as withing 3 to 5 months), the patient was diagnosed with Guillain-Barre syndrome. The patient experienced effects that resulted in physical therapy as treatment and additional follow-ups for diagnosis. The patient sought medical attention.  The outcome of Guillain-Barre syndrome and the causal relationship between the events and the suspect therapy were not reported.  Upon internal review, the event Guillain-Barre syndrome was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AEs; an expired dose of V ARlV AX was inadvertently administered to one patient; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 09-MAR-2021, the patient was inadvertently vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S006019, expiration date 27-FEB-2021 (exact dose, anatomical location and route of administration were not reported) for prophylaxis. No additional adverse events (AEs) were reported.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: some excursions were discovered with ROTATEQ; No other adverse events reported; This spontaneous report as received from a physician and his clinical research coordinator and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history.      On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose, orally, lot # 1661000, expiration date on 13-MAY-2021 as prophylaxis (strength, dose, and frequency were not reported).        On unspecified dates, the administered dose of vaccine experienced the following temperatures of excursion: 1.6 degrees Celsius above the recommended storage for a maximum of 19 hours and 31 minutes; on a separate occasion it was exposed to 1.3 degrees Celsius above for a maximum of 16 hours and 49 minutes;  0.6 degrees Celsius above for a maximum of 22 hours and 56 minutes; and 0.6 degrees Celsis above for 22 hours and 56 minutes (Incorrect product storage). There was previous temperature excursion however it was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: her arm was sore; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 81-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient herself. The patient expected her arm to be sore and adds with the 2nd shingles vaccine her arm was sore, which was received years ago from the date of reporting. She did not had any product or information to provide, lot or expiration date the shingles vaccine.  The patient received Pfizer Covid vaccine and experienced arm hurt, quesy and pasty stools. The 2nd dose was scheduled on 6th February 2021.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Loss of personal independence in daily activities
Clinical narrative: I was sick; I was sick in bed for a day after; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and activities of daily living impaired. On an unknown date, the outcome of the sickness and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the sickness and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received the first dose and I was sick in bed for a day after, but would get the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: unspecified injury; This case was reported by a lawyer and described the occurrence of injury in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injury. On an unknown date, the outcome of the injury was unknown.   It was unknown if the reporter considered the injury to be related to Shingrix.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: has body aches; shivering; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd March 2021, 1 days after receiving Shingrix, the patient experienced general body pain and shivering. On an unknown date, the outcome of the general body pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix and next day morning experienced body ache and shivering. The events were not resolved. The patient consented to follow up. There was discrepancy in the reported event onset date of body aches. It is 1st Mar 2021 but as per narrative it is captured as 2nd Mar 2021
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: felt " it run "up her throat and down to her chest causing chest pains; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received first dose on an unknown date.).   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2020, 7 hrs after receiving Shingrix, the patient experienced chest pain. The patient was treated with benadryl (nos) (Benadryl). In November 2020, the outcome of the chest pain was recovered/resolved.   It was unknown if the reporter considered the chest pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. About 7 hours after receiving the second vaccine, the patient felt it run up her throat and down to her chest causing chest pains. She called 911 because she thought she was experiencing a heart attack, then she reported it was not a heart attack. The event was recovered after 24 hours of vaccination. The patient was given Benadryl and sent home. The patient did not consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Product administered at inappropriate site
Clinical narrative: Was given Engerix-B and Hyper HepB immunoglobulin at same anatomical site; This case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a male patient who received HBV (Engerix B) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included IMMUNOGLOBULIN ANTIHEPATITIS B (HYPERHEP B S/D) for prophylaxis.   On 2nd March 2021, the patient received the 1st dose of Engerix B and HYPERHEP B S/D. On 2nd March 2021, unknown after receiving Engerix B and an unknown time after receiving HYPERHEP B S/D, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The patient was born.  The patient received Engerix B and Hyper HepB Immunoglobulin at same anatomical site on 02 Mar 2021, which led to vaccine administered at inappropriate site. As per schedule it should not be given on same site and the reporter was concerned if that would affect the efficacy of the vaccine. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Intercepted product prescribing error
Clinical narrative: a physician prescribed a double dose of Twinrix / to an adult patient who has chronic cirrhosis; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a adult patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included hepatic cirrhosis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a physician prescribed a double dose of Twinrix (at the same time) to an adult patient with chronic cirrhosis and the patient did not receive any dose till the time of reporting, which led to intercepted product prescribing error. The reporter consented to follow up.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: A reaction / generalized hives / reaction all over (from head to toe); A reaction / generalized / rash reaction all over (from head to toe); A reaction / That is itchy; This case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 49-year-old female patient who received HBV (Engerix B) (batch number P4DJ5, expiry date 13th December 2022) for prophylaxis.   Concomitant products included HAV (Havrix) and HBV (Engerix B).   On 12th January 2021, the patient received the 2nd dose of Engerix B (intramuscular). On 12th January 2021, 4 hrs after receiving Engerix B and an unknown time after receiving Havrix, the patient experienced generalized urticaria, generalized rash and pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized urticaria, generalized rash and pruritus were recovered/resolved.   It was unknown if the reporter considered the generalized urticaria, generalized rash and pruritus to be related to Engerix B.  Additional details were provided as follows: The nurse reported that patient herself administered the 1st dose of the Havrix vaccine herself on 19th November 2020. The patient received first dose of Engerix B on 10th December 2020. After 4 hours of second dose patient developed generalized rash, generalized hives and reaction all over from head to toe. Batch number was available as P4BJ5 and updated as P4DJ5 according to sales data sheet. Nurse consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021057745:Same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain
Clinical narrative: first Shingrix vaccination in her left deltoid on 7/23/2020 and has not received 2nd vaccination; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (started years ago from reporting day). Concomitant products included valaciclovir hydrochloride (Valtrex).   On 23rd July 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 23rd July 2020, 6 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced incomplete course of vaccination. On 24th July 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose. The patient received her first Shingrix vaccination in her left deltoid and experienced injection site pain which resolved on next morning.  Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was concerned about efficacy of Shingrix with late 2nd dose. The reporter consented to follow up. This case is linked with case US2021AMR061322, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061322:same reporter
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthmatic crisis, Dizziness, Dyspnoea
Clinical narrative: Asthma Reaction; Dizzy; Lighted headed; Difficulty breathing; A spontaneous report was received from a consumer who is a 29-year-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness, light headed, asthma reaction (asthmatic crisis) and difficulty breathing.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included pantoprazole 40 mg.  On 28-Dec-2020, approximately three hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28-Dec-2020, the patient developed dizziness, became light headed, experienced an asthmatic reaction and difficulty breathing. The events were treated with a dose of albuterol. The patient was transported to the Emergency Room but additional information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, dizziness, light headed, asthma reaction and difficulty breathing was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Gave the wrong vaccine; A spontaneous report was received from a health professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) as a second dose when the initial dose was that of Pfizer's (wrong vaccine administered).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a second dose of Moderna mRNA-1273 mistakenly (Lot number: not provided) for prophylaxis of COVID-19 infection.  On an unknown date, a medical student gave an employee the wrong vaccine for their second dose. They gave Moderna vaccine instead of the Pfizer vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The event gave the wrong vaccine, was considered resolved.  The reporter did not provide an assessment for the event gave the wrong vaccine.; Reporter's Comments: This report refers to a case of (Wrong Product administered) for mRNA-1273, lot # unknown  with no associated AEs.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received her 2nd dose of the Moderna vaccine with 0.4ML dose; A spontaneous report was received from a nurse concerning a 53-year-old female patient, who received Moderna's covid-19 vaccine (mRNA-1273) with 0.4 ml dose (Accidental underdose).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 FEB 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 007M20A, expiry 25th FEB) via unknown route for prophylaxis of COVID-19 infection.  On 08 FEB 2021, the patient received mRNA-1273 vaccine from an health care professional, who administered 0.4 ml lower dose of vaccine. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s), therefore action taken with the drug in response to the event is not applicable.  The outcome of the event received second dose of the Moderna vaccine with 0.4ML dose was recovered.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273 (lot # 007M20A) with no associated AEs reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Possibly 3 doses adminstered to 1 patient; A spontaneous report was received from a HCP concerning about a 74 old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication error of received 3 doses of Moderna COVID-19 vaccine.  The patient's medical history was not reported.  Concomitant medications were not reported.  On 29 Oct 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via an unknown route for prophylaxis of COVID-19 infection.  On 26 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via an unknown route for prophylaxis of COVID-19 infection.  On 23 Feb 2020, prior to the onset of the events, the patient received their third of two doses of mRNA-1273 (Batch number: 043L20A) via an unknown route for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced received 3 dose of Moderna COVID-19 vaccine.  Laboratory tests was not reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event are unknown.  The outcome of event was considered as recovered on 23 Feb 2021.; Reporter's Comments: This report refers to a case of Extra dose administered for mRNA-1273, lot # 043L20A, with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis; A spontaneous report was received from a Non Health Professional concerning a unspecified old, unspecified gender patient was participating in the mRNA-1273 Emergency Use Program and developed cellulitis.  The patient's medical history was not provided by the reporter. Concomitant medications were not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 on unspecified date ( LOT/BATCH: unknown) , intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.  On unspecified date, the patient experienced cellulitis. Treatment history included antibiotic.  Action taken for mRNA-1273 in response to the event was unknown.  The outcome of the event, cellulitis was considered as  unknown.; Reporter's Comments: Based on the 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.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received Moderna Vaccine- under age requirement; A spontaneous report was received from a consumer concerning a 17-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  The consumer received the first of the two planned doses of mRNA-1273 on 15 Jan 2021 (Batch# 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event was resolved.  The assessment was not provided for the event.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 039K20A) with no associated AEs reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site erythema
Clinical narrative: Cellulitis; Red circle and it covered the fleshy part of her arm; A spontaneous report was received from a consumer concerning a 78-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed red circle and it covered the fleshy part of her arm/vaccination site erythema and cellulitis.  The patient's medical history was not reported. Concomitant product use was not reported.  On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection.   On 31 Jan 2021, approximately four days after receiving the vaccine, the patient developed a red circle and it covered the fleshy part of her arm. She was put on antibiotics for cellulitis and after a couple of days it went away, but she finished the seven days of antibiotics.  On 14 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection.  Action taken with mRNA-1273 in response to the events was continued.   The outcome of the events, vaccination site erythema and cellulitis were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Loss of consciousness, Pain in extremity, Time perception altered, Vomiting
Clinical narrative: Sore arm; Passed out; loss sense of time for 36 hr; so weak to get up; Vomiting for several time; A spontaneous report was received from a consumer, who  was  a 92 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, lose the sense of time, vomiting for several time, so weak to get up and passed out.  The patient's medical history included cancer, restless leg syndrome, allergies to shellfish and currently living in hospice. Concomitant products included rivaroxaban, digoxin, diltiazem, omeprazole, pramipexole, vitamin D3, budesonide and paracetamol prn.  On 19 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date after receiving the vaccine, the patient experienced sore arm. One night, she lost the sense of time for 36 hours. She got up in the middle of night and went to bathroom and was vomiting for several time. She then got back to bed with waste basket and was so weak to get up. She called the nursing home next door and she believed that they may have called 911 but was not full sure if they did or did not. The next day morning, one of the neighbors came to check on her at 11 am. When the neighbor tried to wake her up, she was passed out therefore the nursing home called 911 again. Patient believed that nurse gave her a shot to stop vomiting but do not clearly remember. She was not planning on getting the second dose of the vaccine. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, sore arm and so weak to get up, were unknown.  The outcome of the events, lose the sense of time and passed out, were considered resolved on 22 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Myalgia, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Blood clot on right lung; soreness in arm; A spontaneous report was received from  a 72 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced blood clot on right lung  (pulmonary embolism) and myalgia.  The patient's medical history was not provided. The patient had family history of blood clot (mother and brother). No concomitant product use was reported.  On 02-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient had soreness in the right arm which subsided couple of days later. The patient also experienced shortness of breath for a week after vaccine administration. On 17-Feb-2021, the patient went to the hospital and underwent COVID-19 virus test, the results of which were negative. On 17-Feb-2021, the computerized tomography scan on chest showed moderate size blood clot on right lung. On 18-Feb-2021, the patient was discharged from the hospital on recommendation to initiate and continue lifetime treatment with Eliquis (apixaban, 5mg every 12 hours). According to the physician, moderate size blood clot on right lung of the patient could be attributed to the genetic history (patient's mother and brother also had blood clot). The patient also followed up with primary care physician, who informed that it was genetic and not related to vaccine.  Action taken with mRNA-1273 was not reported.  The outcome of the events, pulmonary embolism was unknown. The outcome of the event, myalgia was considered as recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Asphyxia, Blood pressure abnormal, Heart rate increased, Hypersensitivity
Clinical narrative: Asphyxiation; like had a heart attack; Blood pressure was 150/90; sever allergic reaction; lethargic; Arrhythmia; Fast heartbeat; A spontaneous report was received from a 46 year old female who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced asphyxiation, fast heartbeat, lethargy, blood pressure 150/90, arrhythmia and a heart attack like episode.  The consumer received the first of the two planned doses of mRNA-1273 on 05-FEB-2021 (Batch #: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 06-FEB-2021, Patient experienced fast heartbeat.   On 07-FEB-2021, she became lethargic.     On 08-FEB-2021, she called the EMT due to complaints of rapid heartbeat as if she was experiencing arrhythmia. The patient stated that her blood pressure was 150/90, as well as, she had asphyxiation and felt like she had a heart attack.   No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myocardial infarction
Clinical narrative: Asphyxiation; like had a heart attack; Blood pressure was 150/90; sever allergic reaction; lethargic; Arrhythmia; Fast heartbeat; A spontaneous report was received from a 46 year old female who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced asphyxiation, fast heartbeat, lethargy, blood pressure 150/90, arrhythmia and a heart attack like episode.  The consumer received the first of the two planned doses of mRNA-1273 on 05-FEB-2021 (Batch #: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 06-FEB-2021, Patient experienced fast heartbeat.   On 07-FEB-2021, she became lethargic.     On 08-FEB-2021, she called the EMT due to complaints of rapid heartbeat as if she was experiencing arrhythmia. The patient stated that her blood pressure was 150/90, as well as, she had asphyxiation and felt like she had a heart attack.   No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Husband experienced seizure lasting 30min. after taking 2nd vaccine. 1st vaccine on 26/01/21 LOT# 00TM20A.  2nd on 23/02/21 LOT# 024M20A,5 Days after; the Ambulance took husband to hospital & Dr put the patient on a seizure med Levetiracitam 500mg; A spontaneous report  was received from a consumer, concerning 87-year-old male patient, who received his second dose of Moderna's COVID-19 vaccine and experienced seizure that lasted about a half an hour.  Medical history included: seizure 37 years ago during a stroke. There were no concomitant medications reported.  On 26-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: LOT# 00TM20A) and on 23-Feb-2021, he received the second dose of mRNA-1273 (LOT# 024M20A), intramuscularly for prophylaxis of COVID-19 infection.  On 28-Feb-2021, five days post receive the vaccine, the patient experienced a seizure which lasted about a half an hour. The patient was taken to hospital and was treated with Levetiracitam 500mg.  Action taken with the dose of mRNA-1273 in response to the event was not reported.   The outcome for the event was considered as resolved on 28-Feb-2021.; Reporter's Comments: Based on the current available information which show a temporal association between the use of the product and excluding all other etiologies as reported (subject experienced seizure 37 years ago), a causal relationship with the event cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Flushing, Product dose omission issue, Tachycardia
Clinical narrative: mild anaphylactic shock; Tachycardia; deep Flush; Missed dose; A spontaneous report was received from a nurse concerning a female patient of 27 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced tachycardia,deep flush and anaphylactic reaction.  The patients medical history was not provided.No relevant Concomitant medications were reported.   On 09 jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 037K20A ) vaccine for prophylaxis of COVID-19 infection.  On an unknown date,patient experienced mild anaphylactic shock to vaccine and developed tachycardia and deep flush. No Treatment information for the event was provided. At the time of the report it as 42 days since the first dose, and patient has not received the second dose.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event tachycardia,deep flush and anaphylactic reaction was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Hospitalised with heart condition; This spontaneous report was received from a nurse concerning, a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized with a heart condition/heart disorder.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 07 Feb 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient was hospitalized for a heart condition. No treatment information was provided.  Action taken with suspect drug mRNA-1273 was unknown.  The outcome of the event, hospitalized with a heart condition, was unknown.; Reporter's Comments: The events were consistent with increased risk of cardiovascular complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: blood clot in left forearm; Sore arm; A spontaneous report was received from a consumer concerning a78, year, old, female patient who developed a blood clot in the left forearm.   The patient's medical history included hypertension, hiigh cholesterol and hypothyroidism.  On 19-JAN-2021 the patient had two stents placed in her heart. Products known to have been used by the patient, within two weeks prior to the event, included clopidogrel bisulfate (One 5 milligram AM and PM) and apxaban (One 5 milligram AM and PM) and Asprin.   On 10-FEB-2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    The patient had a sore arm for about a day after the vaccination.  Six days later the left arm was red and swollen, inside forearm four inches down below the elbow it was stinging, slightly swollen, just to a soft touch she felt lumps of swelling. The patient went to the emergency room and had blood work and an ultrasound.  The emergency room doctor told her that she had a blood clot in the left forearm four inches down below the elbow. The lab test done at the emergency were blood work and ultrasound. Treatment for the event included changing her current medication to one clopidogrel bisulfate  5 milligrams AM and PM and apxaban  two tablets of 5 milligrams AM and PM and to discontinue the Asprin for one week.    There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s) and is scheduled to get her second vaccination 10-MAR-2021.  The outcome of the events were considered as unknown.  Follow up: No follow up information received.; Reporter's Comments: Based on the 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypotension, Syncope, Vaccination site pain
Clinical narrative: almost fainted; low blood pressure; sore arm; shaking (chills); A spontaneous report was received from a forty-nine-years old female consumer, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced low blood pressure, almost fainted, sore arm and shaking (chills).  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received the first of the two planned doses of mRNA-1273 on 25-Jan-2021 (Batch# 041L20A) intramuscularly for prophylaxis of COVID-19 infection. Approximately 12 hours later , she experienced low blood pressure, almost fainted, had sore arm and had  shaking (chills).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported  The outcome of the events was reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events 12 hours after vaccination, a causal relationship cannot be excluded. Further information has been requested