chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: moderate injection site pain, fatigue, headache, muscle pain, joint pain, chills, mild nausea, mild fever. All symptoms started about 18 hrs. after injection and resolved by about 30 hrs. after injection.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Fatigue, Pain
Clinical narrative: 101 fever (w/tylenol), chills, body aches, fatigue, chest tightness and chest pain(only for 1 hour)--all resolved in 48 hours
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101 fever (w/tylenol), chills, body aches, fatigue, chest tightness and chest pain(only for 1 hour)--all resolved in 48 hours
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Within one half hour of receiving the vaccine. Patient became puritic all over and developed a rash to her back. Patient took Benadryl and symptoms were relieved by 1630 of the same day.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: fatigue, fever, nausea, vomiting, diarrhea, weakness
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fatigue, fever, nausea, vomiting, diarrhea, weakness
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, and swelling throughout entire upper left arm around injection site. Icing area 3 times per day for 10 minutes. Physician notified. Redness remains today, 1/25/21.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: 7 days after vaccine, 1/20/2021 shot site red, itchy, and raised.  1/21/2021 entire shoulder swollen, itchy, hot to the touch. Began antihistamine and anti-inflammatories. 1/22/2021 area still hot to the touch, spread past previous borders but not as swollen. The nurse, returned call and asked me to report as an adverse reaction and ask for protocols.  Left message but have not gotten a response.  Antihistamine and anti-inflammatory continued to present, 1/25/2021, area still red and warm to the touch, progressed around bicep area,
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chest pain, Feeding disorder, Full blood count
Clinical narrative: Everything started Saturday morning 1/23/2021. headache, hand so cold, nausea, upset stomach, chest pain, weak,  called the ambulance. was told blood pressure was really high and put warm blankets on me , couldn't eat anything.  was able to eat something yesterday. (sunday)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypertension, Peripheral coldness, X-ray
Clinical narrative: Everything started Saturday morning 1/23/2021. headache, hand so cold, nausea, upset stomach, chest pain, weak,  called the ambulance. was told blood pressure was really high and put warm blankets on me , couldn't eat anything.  was able to eat something yesterday. (sunday)
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: High Fever, Chills, Shaking, Body Aches
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Dizziness, Headache
Clinical narrative: Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills.  Extreme pain lasted from 0140- 0500, but continued with  the skin tenderness, chills, headache and joint pain.  Took Tylenol.  Got up once and thought I would pass out.  Started resting some around 7am.  Drank plenty of fluids.  Drained all day.  Saturday morning headache, nasal congestion, joint pain, hard to get out of bed.  Drained all day.  Sunday feeling better, but lethargic.  Monday back to work.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nasal congestion, Pain in extremity, Pain of skin
Clinical narrative: Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills.  Extreme pain lasted from 0140- 0500, but continued with  the skin tenderness, chills, headache and joint pain.  Took Tylenol.  Got up once and thought I would pass out.  Started resting some around 7am.  Drank plenty of fluids.  Drained all day.  Saturday morning headache, nasal congestion, joint pain, hard to get out of bed.  Drained all day.  Sunday feeling better, but lethargic.  Monday back to work.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Chromaturia, Nausea, Neck pain
Clinical narrative: Nausea and violent vomiting for 2 hours.   Upper back and neck pain for 36 hours.  Chills and shaking for 12 hours.  Urine is now colorless instead of yellow-orange.  I have had no treatment.  Urine remains colorless, but other symptoms are almost resolved.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Nausea and violent vomiting for 2 hours.   Upper back and neck pain for 36 hours.  Chills and shaking for 12 hours.  Urine is now colorless instead of yellow-orange.  I have had no treatment.  Urine remains colorless, but other symptoms are almost resolved.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a registered nurse and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), lot# T021638, expiry date: 21-FEB-2021 (formulation, strength, dose, dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -13.3 degrees Celsius for 4 hours and 15 minutes. There were no previous excursions related. Data logger was involved.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: report a temperature excursion; No other AE reported; This spontaneous report was received from an other type of reporter and  refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  On 12-JAN-2021, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T007790 with expiration date on 03-DEC-2021, 0.5 milliliter for prophylaxis (route of administration was not reported). However, no adverse events were reported.   This temperature excursion occurred on an unknown date, at a 31.2 F temperature for 30 minutes. There was no previous temperature excursion reported and the call was due to data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: pain of her elbow of her left arm; difficult for her to lift things; This case was reported by a consumer via call center representative and described the occurrence of pain in elbow in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in elbow and injected limb mobility decreased. On an unknown date, the outcome of the pain in elbow and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in elbow and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter stated that in 2020 his wife has received dose 1 and dose 2 of Shingrix and then later a flu shot. The reporter did not have the exact dates of the shots but did provide the pharmacy's phone number so that we could obtain the dates of the injections, lot number/exp date, and confirm if they were given intramuscularly. The reporter did not specified the brand name of the flu shot. A few weeks ago or last couple of months the patient begin experiencing pain of her elbow of her left arm making it difficult for her to lift things. (The left arm was the arm where she received the second Shingrix shot). The reporter was wondering if this was due to the Shingrix shot,this has not resolved and it has been over 30 days. The reporter did not have his wife's MD contact information available. The information regarding consent to follow up was not reported. This case was linked with case US2020236580.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236580:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site swelling
Clinical narrative: muscle pain; shivering / CHILLS; diarrhea; swollen area around the injection site; sore arm; exhaustion; experienced headache; achiness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, chills, diarrhea, injection site swelling, pain in arm, exhaustion, headache and pain. On an unknown date, the outcome of the muscle pain, chills, diarrhea, injection site swelling, pain in arm, exhaustion, headache and pain were unknown.   It was unknown if the reporter considered the muscle pain, chills, diarrhea, injection site swelling, pain in arm, exhaustion, headache and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The patient experienced headache, achiness, exhaustion, sore arm, chills, swollen area around the injection site, diarrhea, shivering, and muscle pain after receiving the first dose of Shingrix vaccine. The reporter stated that experienced the events but did not have specific patient identifiers. The reporter did not obtain any additional information from caller because adverse events filed after the call. The reporter did not gave consent to follow-up. This case had been linked with US2020239760, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239760:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: muscle pain; shivering / CHILLS; diarrhea; swollen area around the injection site; sore arm; exhaustion; experienced headache; achiness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, chills, diarrhea, injection site swelling, pain in arm, exhaustion, headache and pain. On an unknown date, the outcome of the muscle pain, chills, diarrhea, injection site swelling, pain in arm, exhaustion, headache and pain were unknown.   It was unknown if the reporter considered the muscle pain, chills, diarrhea, injection site swelling, pain in arm, exhaustion, headache and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The patient experienced headache, achiness, exhaustion, sore arm, chills, swollen area around the injection site, diarrhea, shivering, and muscle pain after receiving the first dose of Shingrix vaccine. The reporter stated that experienced the events but did not have specific patient identifiers. The reporter did not obtain any additional information from caller because adverse events filed after the call. The reporter did not gave consent to follow-up. This case had been linked with US2020239760, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239760:same reporter
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Dizziness
Clinical narrative: experiencing dizziness /  lightheadedness; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased (high cholesterol).   On 27th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th November 2020, less than a day after receiving Shingrix, the patient experienced light headedness. On an unknown date, the outcome of the light headedness was not recovered/not resolved.   It was unknown if the reporter considered the light headedness to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The patient received vaccine in his right upper arm and he experienced dizziness and lightheadedness at the evening of getting the vaccine. These adverse events were lasted for the past seven days and are were still ongoing at the time of reporting. The patient had been feeling dizzy every day since getting the vaccine and he had visited his doctor and had bloodwork done; he was told by his doctor that everything was fine and he was not sure what might have caused the adverse reactions. The bloodwork showed high cholesterol, which patient had for a long time. The patient gave permission to follow-up with their health care professional and unable to provide health care professional's email/fax at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pruritus, Vomiting
Clinical narrative: itches in the skin; vomiting; dose of Shingrix on October 28, 2020 / got her second dose on November 30, 2020; This case was reported by a pharmacist via call center representative and described the occurrence of itchy skin in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 30th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 2nd December 2020, the patient experienced itchy skin and vomiting. On an unknown date, the outcome of the itchy skin, vomiting and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the itchy skin and vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 28th October 2020, the patient received 1st dose of Shingrix. The patient received 2nd dose earlier than the recommended schedule, which led to shortening of the vaccination schedule. The patient experienced itches in the skin and vomiting, 2 days after vaccination. The consent to follow-up was granted.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: 2 spots on injection arm / look scaly; Redness at site of injection; Pain / at site of injection; This case was reported by a pharmacist and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 6th May 2022) for prophylaxis.   Concurrent medical conditions included pinched nerve (in neck).   On 9th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the patient experienced rash scaly. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the rash scaly was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, rash scaly and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the left arm. The patient experienced pain and redness at site of injection of Shingrix. At the time of reporting, the patient had two spots on injection arm which were the size of a mosquito bite and look scaly. The patient would follow-up with her doctor. The reporter did not consent to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Body temperature increased, Dizziness, Headache, Impaired work ability
Clinical narrative: sleeplessness; dizziness; shakiness; body aches; headaches; nauseous; stomach ache; temperature of 102.1; had to leave work; This case was reported by a nurse and described the occurrence of sleeplessness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 31st August 2020 and experienced injection site erythema and injection site pain. For the tolerance of 1st dose, refer case US2020AMR261059).   On 15th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 15th December 2020, less than a day after receiving Shingrix, the patient experienced sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell. On an unknown date, the outcome of the sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell were unknown.   It was unknown if the reporter considered the sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced sleeplessness, dizziness, shakiness, body aches, headaches, temperature of 102.1-degree Celsius, stomachache and was nauseous. The patient was an operating room nurse and had to leave work. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR261059:1st dose
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Insomnia, Malaise, Nausea
Clinical narrative: sleeplessness; dizziness; shakiness; body aches; headaches; nauseous; stomach ache; temperature of 102.1; had to leave work; This case was reported by a nurse and described the occurrence of sleeplessness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 31st August 2020 and experienced injection site erythema and injection site pain. For the tolerance of 1st dose, refer case US2020AMR261059).   On 15th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 15th December 2020, less than a day after receiving Shingrix, the patient experienced sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell. On an unknown date, the outcome of the sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell were unknown.   It was unknown if the reporter considered the sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced sleeplessness, dizziness, shakiness, body aches, headaches, temperature of 102.1-degree Celsius, stomachache and was nauseous. The patient was an operating room nurse and had to leave work. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR261059:1st dose
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tremor, Vaccine positive rechallenge
Clinical narrative: sleeplessness; dizziness; shakiness; body aches; headaches; nauseous; stomach ache; temperature of 102.1; had to leave work; This case was reported by a nurse and described the occurrence of sleeplessness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on 31st August 2020 and experienced injection site erythema and injection site pain. For the tolerance of 1st dose, refer case US2020AMR261059).   On 15th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 15th December 2020, less than a day after receiving Shingrix, the patient experienced sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell. On an unknown date, the outcome of the sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell were unknown.   It was unknown if the reporter considered the sleeplessness, dizziness, tremor, general body pain, headache, nausea, stomach pain, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced sleeplessness, dizziness, shakiness, body aches, headaches, temperature of 102.1-degree Celsius, stomachache and was nauseous. The patient was an operating room nurse and had to leave work. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR261059:1st dose
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Pain at the site of injection; Received a double dose (1mL); A spontaneous report was received from a consumer who was an 29-year-old, male patient who was participating in the mRNA-1273 Emergency Use Program and received a double dose (1ml) and the patient experienced pain at the site of injection.    The patient's medical history was not provided. No concomitant medications were reported.  On 13-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On the same day, the patient stated that he received a double dose (1ml) and experienced pain at the site of injection.   No treatment was administered.   Action taken with mRNA-1273 in response to the events was not provided.  The event, received a double dose (1ml), was considered resolved on 13-Jan-2021. The outcome for the event, pain at the site of injection was not resolved.; Reporter's Comments: This case concerns a 29-year-old, male patient, who experienced a non-serious, unexpected event of extra dose administered and a non-serious expected event of injection site pain. There were no reported AEs associated with this case of extra dose administered. However, the event of injection site pain occurred same day after the first dose of mRNA-1273 (Lot number: 041L20A) administration. The event of extra dose administered was assessed as not-applicable. Based on the current available information and temporal association between the use of the product and the start date of the event  injection site pain, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient got 0.4mL of the Moderna dose; A spontaneous report was received from a nurse concerning an unidentified patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got 0.4mL of the Moderna dose, instead of the 0.5mL.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient got 0.4mL of the Moderna dose, instead of the 0.5mL. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, patient got 0.4mL of the Moderna dose, instead of the 0.5mL, was considered resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose at day 15; A spontaneous report was received from a pharmacist concerning a 91-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received 2nd dose at day 15.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 026L20A, Exp. date: 28 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection. The pharmacist reported that the patient received their 2nd dose 15 days after the 1st dose instead of on day 28 which was the recommended return vaccination date. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, received 2nd dose at day 15 was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (Lot number: 026L20A). There were no reported AEs associated with this case of Inappropriate schedule of product administration.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old employee inadvertently was given the Moderna product; A spontaneous report was received from a pharmacist concerning a 16-year-old, patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The pharmacist stated that a 16-year-old employee inadvertently was given the Moderna product. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 16-year-old employee inadvertently was given the Moderna product, was considered resolved.; Reporter's Comments: This report refers to a case of 16-year-old employee inadvertently was given the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. There were no reported AEs associated with this case of  "16-year-old employee inadvertently was given the Moderna product".
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine administered subcutaneously; A spontaneous report was received from a healthcare professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of received vaccine subcutaneously.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) subcutaneously for prophylaxis of COVID-19 infection.  On an unspecified date the patient received the vaccine subcutaneously.    No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event received vaccine subcutaneously was considered resolved.  The reporter did not provide a causality assessment of the event.; Reporter's Comments: This report refers to a case of  incorrect route of product administration (subcutaneously instead of intramuscularly) for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of incorrect route of product administration. Reported event is unlisted for mRNA-1273  and causality was assessed as not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Product administered at inappropriate site
Clinical narrative: Patient was injected in his left arm - medial location in front of elbow; Redness at injection site; A spontaneous report was received from a health care professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of received vaccine on medial location of left arm two fingers above the elbow and experienced redness at the site of injection.  The patient's medical history was not provided. Concomitant medications were not reported.  On 12-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 12-Jan-2021, the patient received vaccine on medial location of left arm two fingers above the elbowand experienced redness at the site of injection.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The event patient was injected in his left arm - medial location in front of elbow was resolved. The outcome of the event redness at the site of injection was unknown.  The reporter did not provide a causality assessment of the events.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273 and concerns a male patient (age unknown), who experienced the event of injection site erythema. The event occurred approximately the same day after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Syringe leaked and only part of the first dose was administered; Syringe leaked; A spontaneous report was received from a consumer concerning a male patient of unknown age who was participating in the mRNA-1273 Emergency Use Program who received only part of the first dose due to the syringe leaking.     The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 14-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (Lot 021L20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   The consumer reported that during administration, product leaked from the syringe and sprayed on his arm. He estimates that he only received 0.25 mL of the dose.   Treatment for the event was not provided.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event was resolved.; Reporter's Comments: This report refers to a male patient of unknown age who received only part of the first dose due to the syringe leaking for product mRNA-1273 (Lot 021L20A). There were no reported AEs associated with this case of only part of the first dose due to the syringe leaking.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of vaccine dripped on patient's arm; A spontaneous report was received from a health care professional concerning a 33-years old female patient, who received the Moderna COVID-19 Vaccine (mRNA-1273) and some of vaccine dripped on patient's arm (Incorrect dose administered).  There were no medical history concomitant medications provided by the reporter.  On 16-Jan-2021, the patient received the first of two planned doses of mRNA-1273 vaccine (Lot number: 025J20-2A) intramuscularly in the right arm for COVID-19 infection prophylaxis.   The HCP stated that, while the vaccine was being administered to the patient, a good amount of the vaccine dripped down her arm because the needle was retracted too quickly. No other adverse event was reported, and the patient provided consent for follow-up. No treatment information was provided for the event.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event some of vaccine dripped on patient's arm (Incorrect dose administered) was considered recovered on 16-Jan-2021.; Reporter's Comments: This case concerns a 33 year old female patient who experienced a non-serious unexpected event of Incorrect dose administered of the mRNA-1273 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: All of the liquid ran (dripping) down his arm and fingers; A spontaneous report was received from a healthcare professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, all the liquid ran (dripping off) down his arms and fingers.  The patient's medical history was not provided. Concomitant medications were not reported.  On 07-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 07-Jan-2021, the patient received the vaccine and all the liquid ran (dripping off) down his arms and fingers.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event all the liquid ran (dripping off) down his arms and fingers was considered resolved.  The reporter did not provide a causality assessment of the event.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given subcutaneously; A spontaneous report was received from a pharmacist concerning an 89-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and vaccine was administered subcutaneously.  The patient's medical history was not provided. The patient current conditions included ulcers and high blood pressure. Concomitant medications was not specified.  On 18-Jan-2021, approximately 0 days prior to the onset of the event, the patient received a dose of mRNA-1273 subcutaneously for prophylaxis of COVID-19 infection.  On 18-Jan-2021, the patient received the vaccine subcutaneously. The reporter noticed from a picture that it was not administered intramuscularly.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event vaccine administered subcutaneously was considered resolved on 18 Jan 2021.  The reporter did not provide a causality assessment of the event incorrect route of product administration.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient really shot the next day got sick; Initial information was received on 16-Jan-2021 regarding an unsolicited valid non-serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who got sick (illness), while being received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient was sick the next day (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.
Age: 64.0
Sex: M
Vaccine: FLUC3
Symptoms: Dizziness, Nausea, Nystagmus, Vertigo, Vomiting
Clinical narrative: Vertigo; Nystagmus; He could not get up; Dizziness; He felt like he was going to pass out and almost did pass out at one point; Nausea; Vomiting; This spontaneous case was received on 24-Dec-2020 from physician via The Agency (reference number: SEQW20-05936) and concerned a 64-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 28-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent vaccine (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for protection against seasonal influenza. The batch number reported was 276541, expiration date: 16-Jun-2021.  On the same day, 10 hours after receiving Flucelvax Quadrivalent, the patient experienced extreme dizziness and vertigo, he stated that that it was real vertigo and severe, with the sensation that the room was spinning. The patient reported that, during this episode, he felt like he was going to pass out and almost did pass out at one point. During this time, he could not get up and was experiencing nystagmus. The patient was experiencing nausea and vomiting during this time. The patient stated that all of these adverse effects lasted about three hours.  On the same day, the patient recovered from all events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company Comment: A 55-year-old female patient developed vertigo, nystagmus, dysstasia, dizziness, presyncope, presyncope, nausea and vomiting on the same day after vaccination with the suspect product, Flucelvax Quadrivalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on plausible time relationship, causality cannot be totally excluded and is assessed as possibly related.; Sender's Comments: A 55-year-old female patient developed vertigo, nystagmus, dysstasia, dizziness, presyncope, presyncope, nausea and vomiting on the same day after vaccination with the suspect product, Flucelvax Quadrivalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on plausible time relationship, causality cannot be totally excluded and is assessed as possibly related.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: 12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into  sweating/heat. Mild upset stomach throughout.  Soreness/brusing at injection site.  After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Pain, Tremor
Clinical narrative: 12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into  sweating/heat. Mild upset stomach throughout.  Soreness/brusing at injection site.  After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pharyngeal oedema, Pharyngeal swelling, Retching
Clinical narrative: Patient presented to ED shortly after vaccination. Reported throat swelling, became nauseous, and was gagging on her saliva. Posterior oropharynx edema was noted. Treated with epinephrine, methylprednisolone, diphenhydramine, and famotidine. Was observed for several hours and discharged in stable condition.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: Upper back pain which progressed to severe neck pain and headaches, fatigue, mild nausea, all of the symptoms tended to get wax and wean for the next 2 weeks.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Upper back pain which progressed to severe neck pain and headaches, fatigue, mild nausea, all of the symptoms tended to get wax and wean for the next 2 weeks.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Hypertension
Clinical narrative: Patient developed some chest tightness and hypertension approximately an hour after receiving second vaccination.  No evidence of pharyngeal swelling.  Patient was treated with diphenhydramine 50 mg and methylprednisolone 125 mg.  He was discharged without further complications.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Resident reports that her arm is swollen a lot from vaccine. Pain also present.  No treatment at this time.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The area where the shot was administered is itchy, red and slightly swollen.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Skin warm
Clinical narrative: Developed large red rash covering majority of upper left arm. Rash was itchy & hot to the touch. Rash appeared 1 week after first dose of Moderna COVID vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Peripheral coldness
Clinical narrative: 1:32 Shivering and fatigue, chills; BP: 132/35, O2: 97%, HR: 70, Temp: 98.4, Med team alerted; Non-verbal at baseline, hands cold, wearing gloves; (Given warm compress for hands) 1:43: Back to baseline per family, BP: 131/54, MAP: 67, continued observation 1:50: Observation ended, left with 2 family members
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Rash
Clinical narrative: Thursday muscle / body aches with fatigue. Friday rash and my eye. Still having fatigue off and on.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Dehydration, Dyspnoea, Fatigue
Clinical narrative: 1/8/21 evening: arm swelling (baseball-size circumference surrounding vaccination site), onset of fatigue 1/9/21 morning: onset of dehydration, worsening of arm soreness (limited ROM) 1/9/21 evening: fever--onset near 10PM (unsure of highest temp. Temp after 400 mg ibuprofen: 99.6 F. Fever broke after 3AM.), body aches (mild-moderate in both arms, all fingers, back, and both knee 1/10/21 evening: shortness of breath/coughing fits (required use of inhaler--3 puffs with symptom onset. Mild shortness of breath for remainder of day w/o need for inhaler), mild altered taste (only lasted approx.2-3 hours) 1/11/21: onset of arm itchiness surrounding site of vaccination, frequent urination (at least every hour) 1/12/21: worsening of arm itchiness (itches from shoulder to elbow), ROM improving at this point but still painful to touch 1/13/21 morning: worsening of dehydration (back pain, headaches, muscle cramps), arm itchiness improving at this point 1/13/21 evening: urination frequency returning to normal, back aches (from dehydration, less severe than morning), headaches continuing (less pain with ibuprofin, but on/off pain still present), nausea improving at this point 1/13-1/14: late start to menstrual cycle 1/14/21: most symptoms improving at this point, headaches and nausea still mild 1/19/21: first full day with no nausea 1/21/21: first full day with no headaches 1/22/21: symptom-free
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular, Muscle spasms, Nausea, Pain
Clinical narrative: 1/8/21 evening: arm swelling (baseball-size circumference surrounding vaccination site), onset of fatigue 1/9/21 morning: onset of dehydration, worsening of arm soreness (limited ROM) 1/9/21 evening: fever--onset near 10PM (unsure of highest temp. Temp after 400 mg ibuprofen: 99.6 F. Fever broke after 3AM.), body aches (mild-moderate in both arms, all fingers, back, and both knee 1/10/21 evening: shortness of breath/coughing fits (required use of inhaler--3 puffs with symptom onset. Mild shortness of breath for remainder of day w/o need for inhaler), mild altered taste (only lasted approx.2-3 hours) 1/11/21: onset of arm itchiness surrounding site of vaccination, frequent urination (at least every hour) 1/12/21: worsening of arm itchiness (itches from shoulder to elbow), ROM improving at this point but still painful to touch 1/13/21 morning: worsening of dehydration (back pain, headaches, muscle cramps), arm itchiness improving at this point 1/13/21 evening: urination frequency returning to normal, back aches (from dehydration, less severe than morning), headaches continuing (less pain with ibuprofin, but on/off pain still present), nausea improving at this point 1/13-1/14: late start to menstrual cycle 1/14/21: most symptoms improving at this point, headaches and nausea still mild 1/19/21: first full day with no nausea 1/21/21: first full day with no headaches 1/22/21: symptom-free
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pollakiuria, Pruritus, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 1/8/21 evening: arm swelling (baseball-size circumference surrounding vaccination site), onset of fatigue 1/9/21 morning: onset of dehydration, worsening of arm soreness (limited ROM) 1/9/21 evening: fever--onset near 10PM (unsure of highest temp. Temp after 400 mg ibuprofen: 99.6 F. Fever broke after 3AM.), body aches (mild-moderate in both arms, all fingers, back, and both knee 1/10/21 evening: shortness of breath/coughing fits (required use of inhaler--3 puffs with symptom onset. Mild shortness of breath for remainder of day w/o need for inhaler), mild altered taste (only lasted approx.2-3 hours) 1/11/21: onset of arm itchiness surrounding site of vaccination, frequent urination (at least every hour) 1/12/21: worsening of arm itchiness (itches from shoulder to elbow), ROM improving at this point but still painful to touch 1/13/21 morning: worsening of dehydration (back pain, headaches, muscle cramps), arm itchiness improving at this point 1/13/21 evening: urination frequency returning to normal, back aches (from dehydration, less severe than morning), headaches continuing (less pain with ibuprofin, but on/off pain still present), nausea improving at this point 1/13-1/14: late start to menstrual cycle 1/14/21: most symptoms improving at this point, headaches and nausea still mild 1/19/21: first full day with no nausea 1/21/21: first full day with no headaches 1/22/21: symptom-free