chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Bone pain, Chills, Exposure during pregnancy, Fatigue
Clinical narrative: EDD 04/15/2021 Pregnancy history: hyperemesis gravitorium POTS pSVT Started feeling bad and fatigued  around 9pm. Woke up with chills, severe body aches and bone pain, severe left arm pain, headache, nausea at 11pm. Felt worst I had ever felt in my life. Couldn?t get out of bed due to severe pain. Temp max 101. Lasted until 1pm next day and then resolved however felt tired for several days after and had episodes of tachycardia and pSVT for 2days after (h/o POTS and pSVT and think dehydration from episode with nausea and fever probably caused that)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: EDD 04/15/2021 Pregnancy history: hyperemesis gravitorium POTS pSVT Started feeling bad and fatigued  around 9pm. Woke up with chills, severe body aches and bone pain, severe left arm pain, headache, nausea at 11pm. Felt worst I had ever felt in my life. Couldn?t get out of bed due to severe pain. Temp max 101. Lasted until 1pm next day and then resolved however felt tired for several days after and had episodes of tachycardia and pSVT for 2days after (h/o POTS and pSVT and think dehydration from episode with nausea and fever probably caused that)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Postural orthostatic tachycardia syndrome, Supraventricular tachycardia, Tachycardia, Vomiting
Clinical narrative: EDD 04/15/2021 Pregnancy history: hyperemesis gravitorium POTS pSVT Started feeling bad and fatigued  around 9pm. Woke up with chills, severe body aches and bone pain, severe left arm pain, headache, nausea at 11pm. Felt worst I had ever felt in my life. Couldn?t get out of bed due to severe pain. Temp max 101. Lasted until 1pm next day and then resolved however felt tired for several days after and had episodes of tachycardia and pSVT for 2days after (h/o POTS and pSVT and think dehydration from episode with nausea and fever probably caused that)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Post injection had pain, swelling and redness. After one week it resolved but eight days later on 2/25/21  a rash was noted, red and itchy.  I spoke and showed my arm site to the pharmacist and was instructed to ice it and use a topical anti itch cream. The rash is subsiding but not completely resolved at this time3/2/21
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Post injection had pain, swelling and redness. After one week it resolved but eight days later on 2/25/21  a rash was noted, red and itchy.  I spoke and showed my arm site to the pharmacist and was instructed to ice it and use a topical anti itch cream. The rash is subsiding but not completely resolved at this time3/2/21
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chest X-ray normal, Full blood count normal, Herpes zoster, Hypokinesia
Clinical narrative: Developed severe joint pain and immobility which has affected multiple joints since 2/3/2021 and is still on going. Developed facial and scalp shingles and related low grade fever and flu like symptoms.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Pyrexia, SARS-CoV-2 test negative, Varicella virus test positive
Clinical narrative: Developed severe joint pain and immobility which has affected multiple joints since 2/3/2021 and is still on going. Developed facial and scalp shingles and related low grade fever and flu like symptoms.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Rash, soreness when touched, itchy
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Fatigue, Headache, Pyrexia
Clinical narrative: Burning and redness in both armpits, fever of 100.0 Fahrenheit, headache, fatigue.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen circle 2.5 inches around injection site
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Dyspepsia, Heart rate increased, Hyperhidrosis, Skin discolouration
Clinical narrative: Friday 2-26 had rapid heart rate despite taking ivabradine, fainted 3 times Sunday 2-28. All dysautonomia symptoms increased - sweating, extremities turning purple, syncope, indigestion, etc.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Friday 2-26 had rapid heart rate despite taking ivabradine, fainted 3 times Sunday 2-28. All dysautonomia symptoms increased - sweating, extremities turning purple, syncope, indigestion, etc.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient was accidentally given a Pfizer COVID-19 vaccine for his second dose after receiving Moderna COVID-19 vaccine (Lot 028L20A) for his first dose on 1/20/21. Patient denies any adverse events post vaccination.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: large red rash next to vaccination site. No raised nodules. Didn't itch. No treatment. Eventually faded away
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache onset 24 hours after first dose. Headache onset 1 hour after second dose. Continued headache, body aches 12 hours post second does. Continued headache, body aches chills, nausea and fever (102 max temp) 18 hours post second dose. Body aches, chill and fever until approximately 40 hours post second does. Continued headache and nausea with headache becoming severe 54 hours post second dose.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: ONSET 1 hour after injection. --Swelling of face/hands/arm/feet. Surface veins in hands were black. Tingling of tongue and throat. Severe headache. Body aches. Extreme fatigue.  Pregressing over the three hour period - treated with Benedryl, caffeine, ibuprofin, bed rest for 48 hours.    Symptoms cleared by 72 hours.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Swelling, Vein discolouration
Clinical narrative: ONSET 1 hour after injection. --Swelling of face/hands/arm/feet. Surface veins in hands were black. Tingling of tongue and throat. Severe headache. Body aches. Extreme fatigue.  Pregressing over the three hour period - treated with Benedryl, caffeine, ibuprofin, bed rest for 48 hours.    Symptoms cleared by 72 hours.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Condition aggravated, Fibromyalgia, Gait disturbance
Clinical narrative: Widespread Muscle pain, more so than with just fibromyalgia. lower back and hip pain making it hard to walk.   Still hurting pretty bad after over a week.  Either caused a fibromyalgia flare up or really affected my muscles.  Never had the hip pain like this.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Widespread Muscle pain, more so than with just fibromyalgia. lower back and hip pain making it hard to walk.   Still hurting pretty bad after over a week.  Either caused a fibromyalgia flare up or really affected my muscles.  Never had the hip pain like this.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: nausea, terrible body pain, terrible headaches
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Dry mouth
Clinical narrative: Chills and fever began at approx. 1:30 a.m. on February 27.  Continued until late mid-day on March 1.   Extreme weakness and nausea.  Had no appetite.  Very dry mouth. Fever lessened by evening of March 1. Weakness and feeling of lightheadedness continuing as of today, March 2, morning. No more nausea today. No fever today Able to eat small amount of food
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills and fever began at approx. 1:30 a.m. on February 27.  Continued until late mid-day on March 1.   Extreme weakness and nausea.  Had no appetite.  Very dry mouth. Fever lessened by evening of March 1. Weakness and feeling of lightheadedness continuing as of today, March 2, morning. No more nausea today. No fever today Able to eat small amount of food
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: joint pain; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had joint pain. The reporter asked f it could be a side effect of the 2nd Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: arm be sore and red and itchy / Arm is itchy; arm be sore / Arm is itchy sore; arm be sore and red / Arm is itchy sore red; This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced itchy upper limbs, pain in arm and erythema. On an unknown date, the outcome of the itchy upper limbs, pain in arm and erythema were unknown.   It was unknown if the reporter considered the itchy upper limbs, pain in arm and erythema 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 Shingrix and arm became sore, red and itchy. The reporter asked how long would arm be sore, red and itchy.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dsoe in October 2020, refer case US2021025199.).   On 21st January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing arm soreness in both arms, but more in the arm that was vaccinated in October. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025199:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This case was reported by a consumer via and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had sore arm.  The patient got both doses 6 months apart and got it late in 2019. The patient also got the Pfizer 3 weeks apart. For tolerances of 2nd dose, refer case US2021AMR025854, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025854:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2021AMR025848).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had sore arm.  The doses received 6 months apart and got it late in 2019 and so far so good. The patient also got the Pfizer 3 weeks apart.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025848:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: last one was more painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on unknown date) and Moderna Covid-19 vaccine (Received on unknown date).   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. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain 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 was captured as adult as per vaccine indication. The patient did not have shingles. The patient received the two doses and after last dose was more painful than the Moderna Coivd-19 vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Got the 2 shots / Each time was very ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell 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 unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.  Additional events were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient received 1st dose of Shingles vaccine and was ill. For tolerance of 2nd dose, refer case US2021AMR027665.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027665:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: Got the 2 shots / Each time was very ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of malaise (received 1st dose on unknown date, refer case-US2021AMR027656).   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 unwell. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.  Additional events were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 2nd dose of Shingles vaccine and was ill.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027656:Same reporter.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: After her 2nd shot she felt something trickle down her arm; Possible underdose; A spontaneous report  was received from a healthcare professional concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced events like Vaccine under dose and Vaccination complication.  The patient's medical history not provided. The patient's concomitant not provided  On 13th FEB 2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly in the anatomical location  for prophylaxis of COVID-19 infection.   The patient experienced onset of events of After her 2nd shot she felt something trickle down her arm, possible under dose, and Side effects from the 2nd vaccine were much less than the first.  Treatment was not provided.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the reported events was unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose and exposure via skin for nRNA-1273 with no associated AEs.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Exposure via skin contact
Clinical narrative: Some of the dose ran down the patient's elbow; dose running down patient's elbow; A spontaneous report (UNITED STATES) was received from a pharmacist concerning of a 27 years old, female patient, who received Moderna's COVID-19 vaccine, and who experienced dose of vaccine running down patient's elbow (accidental underdose) (exposure via skin contact).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot number 010M20A) intramuscularly for COVID-19 prophylaxis. During the administration, the vaccine ran down the patient's elbow, and the patient experienced accidental underdose and exposure via skin contact.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose and exposure via skin for mRNA-1273 with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Meningitis viral
Clinical narrative: Viral meningitis; A spontaneous report from  was received from reporter concerning a  patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) on 13 Jan 2021.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On13 January 2021, the patient received their first  dose of mRNA-1273 (lot/batch: Unknown) intramuscularly in the  unknown Anatomical location for prophylaxis of COVID-19 infection.  Patient diagnosed with mild  viral meningitis on 3rd February 2021. Patient experienced intense headaches and sickness. Patient got discharged on 12 February 2021. Treatment for the event included anti viral drip, Celebrex, Benadryl, Tylenol, Elavil.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of viral meningitis was not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: dose given comprised of multiple vials; A spontaneous report was received from a healthcare professional concerning an unknown patient who received Moderna's COVID-19 vaccine (mRNA-1273) and stated that the dose given comprised of multiple vials  No patient details were provided.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, prior to the onset of the events, the patient/patients received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) for prophylaxis of COVID-19 infection.  The reporter stated that 12FEB2021 1 patient would have received a dose from multiple vials and on 13FEB2021 2-3 patients may have received doses from multiple vials.  Laboratory details if provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event ( dose given comprised of multiple vials ) was recovered/resolved..; Reporter's Comments: This case concerns a patient of unknown age and gender who had a nonserious unexpected event of Product preparation issue with mRNA-1273 (lot # 031L20A) without associated adverse events.  Reporter stated a "pharmacy pre-filled syringes and combined the contents of multiple vials to make a single dose, and that multiple patients may have received doses from multiple vials". Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient has not received the second dose yet and more than 2 months has passed since first dose; A spontaneous report was received from a consumer concerning a female patient who experienced patient has not received the second dose yet and more than 2 months has passed since first dose.    The patient's medical history was not provided. No concomitant products were provided.   On 15-JAN-2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient was supposed to get the second dose on 12-FEB-2021, but the facility only had the Pfizer vaccine. The patient tried going to another distribution center but the patient could not get a dose. The patient had an appointment for the second dose on 25-MAR-2021, but that will be more than two months after the first dose. The patient was trying to get a different date for the second dose.     Action taken with mRNA-1273 in response to the event was reported as unknown.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of patient has not received the second dose yet and more than 2 months has passed since first dose for mRNA-1273 (lot# unknown), with no associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Exposure via skin contact
Clinical narrative: concerned that didn't get the entire dose; during administration, some of the liquid dropped on arm; A spontaneous report was received from a nurse, who was also a female patient (age not reported), who received Moderna's COVID-19 vaccine (mRNA-1273) and during administration, some of the liquid dropped on arm (exposure via skin contact) so she was concerned that she didn't get the entire dose (accidental underdose).  The patient's medical history was not provided. No concomitant product use was reported.  The patient received their first of two planned doses of mRNA-1273 (batch number unknown) on an unknown date.  On 16 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number unknown) for prophylaxis of COVID-19 infection.  On 16 Feb 2021, during administration of the vaccine, some of the liquid dropped on her arm so she was concerned that she didn't get the entire dose.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events.  Therefore, the action taken with the drug in response to the events was not applicable.  The events, during administration, some of the liquid dropped on arm and was concerned that didn't get the entire dose, were considered recovered/resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose and exposure via skin contact for mRNA-1273 (lot # unknown), with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received a double dose / pt received 1mL for the dose; A spontaneous report was received from a healthcare professional concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a double dose/accidental overdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient was given a double dose.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event patient received 1mL for the dose was recovered.; Reporter's Comments: This case concerns a male patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Accidental overdose without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under the age of 18 received the 1st dose of the vaccine; A spontaneous report was received from a pharmacist concerning a patient under the age of 18 that received the first dose of Modern's COVID-19 vaccine (mRNA-1273) .  The patient's medical history was not provided.  No concomitant medications were reported.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  No laboratory details were provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events, patient under the age of 18 received the first dose of the vaccine, was not reported.  The outcome of the event, patient under the age of 18 received the first dose of the vaccine, was considered recovered/resolved.; Reporter's Comments: This case concerns a patient under the age of 18 who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Out of specification product use, Product storage error
Clinical narrative: Vials storage error; 10 patients were vaccinated from that vial; A spontaneous report  was received from a pharmacist, concerning ten patients who were administered Moderna's COVID-19 vaccine from a vial temporarily stored at 17.7 °F/product storage error and out of specification product use.  The patients' medical histories were not provided. Concomitant product use was not provided by the reporter.  On 16 Feb 2021, ten patients received one of two planned doses of mRNA-1273 (Batch number 029L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Feb 2021, the freezer door at the pharmacy was left slightly open which resulted in a temperature increase to 17.7 °F for one hour and 25 minutes. After visual inspection by the pharmacist, all vial were reportedly still frozen. The pharmacist thawed 1 vial, and 10 patients were vaccinated from that vial. The pharmacist noted that the temperature of the freezer containing the remaining 29 vials was -11.0 °F at the time of reporting.  Action taken with mRNA-1273 in response to the event was not provided.  The event, 10 patients vaccinated from a vial temporarily stored at 17.7 °F, was considered resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of Product storage error (vaccine from a vial temporarily stored at 17.7 °F, and administered to ten patients) for mRNA-1273, lot # 029L20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose of vaccine on day 27 instead of day 28; A spontaneous report was received from a consumer concerning a female patient (demographics not provided) who received the second dose of Moderna vaccine on day 27 instead of day 28.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On unknown date, the patient received their first of two planned doses of mRNA-1273.   On unknown date, the patient received their second dose of mRNA-1273 (route and site of administration were not provided) for prophylaxis of COVID-19 infection.  On an unknown date, the patient was administered the second dose of vaccine before day twenty-eight. Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event received second dose of vaccine on day 27 instead of day 28 was resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273 with no associated AEs.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: administered a 0.3 ml dose instead of the 0.5 ml dose; A spontaneous report was received from a consumer concerning a 53-year-old, female patient who received Moderna's COVID-19 vaccine and was administered a 0.3 ml dose (MedDRA PT: Incomplete dose administered).   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 15 FEB 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15 Feb 2021, the patient received a call from the pharmacy where she received her vaccine. Patient reports that the lady giving the dose was not used to giving Moderna Covid-19 Vaccine and administered a 0.3 ml dose instead of the 0.5 ml dose. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event was unknown.  The event, administered 0.3 ml dose, was considered recovered/resolved 15 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015255:Lnked case- Sister case
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Received a invalid dose of 0.3 ml; A spontaneous report, was received from a consumer (patient's sister), concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and resulted in patient received an invalid dose of 0.3 ml (underdose).   The patient's medical history was not provided. Concomitant mediation was not reported.    On 15 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   The patient's sister received a call from the pharmacy, and it was reported that the patient received Moderna COVID-19 Vaccine on 15 Feb 2021. The patient's sister reported that the lady giving the dose was not used to give Moderna Covid-19 Vaccine and administered a 0.3 ml dose to the patient instead of the 0.5 ml dose. Treatment information was not provided.    Action taken with second dose of mRNA-1273 in response to the event was unknown.  The event, received an invalid dose of 0.3 ml, was considered recovered/resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of vaccine underdose administered to a male patient for mRNA-1273, (lot # not reported) with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015236:Lnked case- Sister case
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Received 0.3 ml vaccine for first shot; A spontaneous report, was received from a consumer (patient), a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and resulted in patient received 0.3 ml vaccine for first shot (underdose).  The medical history of patient was not provided. Concomitant medication was not provided.  On 16 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   The patient confirmed that she received her first shot of Moderna COVID-19 Vaccine on 16 Feb 2021, and got a call from the pharmacist that she got a lesser dose of 0.3 ml instead of 0.5 ml. But there was no problem if the patient received more than 0.25 ml, or more and the patient will still receive her second shot. The patient was worried and would like to know if the pharmacist said was true and if the dose given to her was effective or not and needs to be repeated. No treatment mediation information was provided.  Action taken with second dose of mRNA-1273 in response to the event was unknown.  The event, received 0.3 ml vaccine for first shot, was considered recovered/resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of underdose for mRNA-1273, with no associated AEs.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Chills, Vaccination site pain, Wrong technique in device usage process
Clinical narrative: Arm has been sore; Chills; when she administered the vaccine she squirted the vaccine on me; nurse then drew up additional vaccine and administered 0.3mL; A spontaneous report was received from a consumer concerning a 42-year-old, male patient who was participating in the mRNA-1273 Emergency Use Program and experienced accidental underdose, extra dose administered, arm has been sore and chills.  The patient's medical history not provided.  Concomitant medications not provided.  On 16-JAN-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that when he received the vaccine, the nurse squirted some of the liquid on him.  He stated that she then went and got more vaccine and administered an additional 0.3mls.  Additionally, he stated that on 17-JAN-2021, his arm was sore and he had chills.   Treatment included Aleve.   Action taken with mRNA-1273 in response to the events, accidental underdose, extra dose administered, arm has been sore and chills, was not provided.  The events, accidental underdose and extra dose administered, were considered recovered/resolved. The outcome of the events, arm has been sore and chills, was unknown.; Reporter's Comments: This case concerns a 42 year old, male patient, who experienced a non-serious expected event of vaccination site pain, and chills, 2 days after receiving 1st dose of mRNA- 1273 (Lot# Unknown). This report also refers to a case of wrong technique in device usage process and accidental overdose for mRNA-1273 (lot # 028L20A), with no associated AEs. 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.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received both doses 11 days apart; A spontaneous report, was received from a pharmacist, concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and resulted in patient received both doses 11 days apart (inappropriate schedule of product administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.     On unknown date, prior to the onset of event, the patient received their second planned dose of mRNA-1273 (Lot number: unknown), intramuscularly for prophylaxis of COVID-19 infection.   The pharmacist reported that the patient received both doses of Moderna COVID-19 vaccine 11 days apart. No treatment information was provided.    Action taken with second dose of mRNA-1273 in response to the event was not applicable.    The outcome of the event, received both doses 11 days apart, was considered as recovered on an unknown date.; Reporter's Comments: This case concerns a male patient of unknown 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: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidently given First dose to 17 year old; A spontaneous report , was received from a pharmacist, concerning a 17 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 18 Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   The pharmacist called in to ask and confirm if he should give the second dose to a 17-year-old patient, who had been accidently given her first dose at the same pharmacy on 18 Jan 2021. The pharmacist did not have any additional patient identifier, or any other information related to this event.  No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, accidently given first dose to 17-year-old, was recovered on 18 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site bruising
Clinical narrative: black bruise at the injection site; concerned that vaccine was not administered intramuscularly; A spontaneous report was received from a patient concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and developed a big black bruise the size of a silver dollar around 3x3 inches at the injection site and was concerned maybe the vaccine was not intramuscularly administered.   The patient's medical history was not provided.    Concomitant medications reported included blood pressure medication and cholesterol medication, however, no product information was provided.  On 27-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 004M20A) in the left arm for prophylaxis of COVID-19 infection.   Patient reported that approximately 1-2 days following vaccine administration, she developed a big black bruise about the size of a silver dollar at the injection site. Additionally, she reported that she was concerned that the vaccine may not have been administered intramuscularly.    No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, developed a big black bruise the size of a silver dollar around 3x3 inches at the injection site, was considered recovering/resolving.  The event, concerned maybe the vaccine was not intramuscularly administered, was considered recovered/resolved.; Reporter's Comments: This case concerns a 73-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot 004M20A) reporting Incorrect route of product administration and Vaccination site bruising. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received the vaccine; A spontaneous report was received from a pharmacist concerning a 16-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event inappropriate age at vaccine administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the events, the 16-year-old patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.    Laboratory details was not provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, inappropriate age at vaccine administration, was considered recovered/resolved.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Product administered at inappropriate site
Clinical narrative: Vaccine administered to high in shoulder; Some of the vaccine dripped down arm; A spontaneous report was received from a consumer concerning a 68-year-old female patient, who received Moderna's COVID-19 vaccine to high in shoulder and some of the vaccine dripped down arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of Covid-19 infection.   The patient stated that the vaccinator administered vaccine too high in the shoulder and some of the vaccine dripped down arm. No further information was provided. Treatment information was unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events "some of the vaccine dripped down arm" and "vaccine administered to high in shoulder" was unknown.; Reporter's Comments: This report refers to a case of underdose, product administered at inappropriate site, and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Some of the vaccine dripped out; some of the vaccine dripped out; A spontaneous report was received from a Consumer concerning a 45 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced device connection issue and vaccine under dose.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 19 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in the left non-dominant arm for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient experienced vaccine dripped out. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events vaccine underdose and device connection issue was unknown.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # 030M20A) with no associated AEs reported.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccinated a pediatric patient; A spontaneous report was received from a healthcare professional concerning a 17 year old pediatric patient who received Moderna's COVID-19 vaccine (mRNA-1273) accidently.  No relevant medical history is provided. No relevant concomitant medications were provided.  On 19 Feb 2021, prior to the onset of the events, the patient received there first of two planned doses of mRNA-1273 (batch: unknown) for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event vaccinated to pediatric patient was resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration for mRNA-1273, lot # unknown, with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Underdose, Vaccination site discharge
Clinical narrative: Vaccine leaked on the site of injection; Didn't receive full vaccine; A spontaneous report was received from a consumer concerning a  73-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced the vaccine leaked on the site of injection (vaccination site discharge) and didn't receive full dose of vaccine (underdose).  The patient's medical history was not reported.  The patient received their second of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 9 FEB 2021, intramuscularly for prophylaxis of COVID-19 infection.  On 09 FEB 2021, Patient reported the vaccine leaked on the site of injection and thinks didn't receive full dose of vaccine.  Action taken with the drug in response to the events was not applicable as the patient received both doses.  The outcome of the events, vaccine leaked on the side of injection and patient didn't receive a full dose, was resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and vaccination site discharge for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Administration lower than the deltoid muscle (she thinks); A spontaneous report was received from a nurse concerning a 41-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) administration lower than the deltoid muscle (Vaccine administered at inappropriate site).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26 Jan 2021, prior to the onset of the event administration lower than the deltoid muscle, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 038K20A) in the right arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient had her second dose of the vaccine on her right arm and she thinks the placement of vaccination was incorrect, lower than the deltoid muscle.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event administration lower than the deltoid muscle was considered recovered.; Reporter's Comments: This report refers to a case of Vaccine administered at inappropriate site for mRNA-1273 (lot/batch: 038K20A) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: given 1ml dose instead of .5ml; A spontaneous report was received from a consumer concerning a 34-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and given 1ml instead of .5ml/accidental overdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient was given 1ml instead of .5ml.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event given 1ml instead of .5ml was considered recovered.; Reporter's Comments: This report refers to a case of Accidental overdose for mRNA-1273.  There were no reported adverse events associated with this case.