chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Ill-defined disorder, Retinal detachment
Clinical narrative: retinal eye detachment; zoster-related eye conditions; other zoster-related conditions; zoster-related eye conditions / other zoster-related conditions; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 13-AUG-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by various healthcare providers, including but not limited to healthcare provider at an eye hospital, as well as other healthcare providers, for zoster-related eye conditions, retinal eye detachment, and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of zoster-related eye conditions, retinal eye detachment, and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of retinal detachment was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No other AE reported; we inadvertently gave a PROQUAD to a patient that was expired; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 22-JAN-2021, the patient was inadvertently vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter (ml) (lot number S022912 which has been verified to be valid, expiration date reported and validated as 19-JAN-2021) (vaccination scheme, route of administration, and anatomical site of injection were not reported) as prophylaxis (expired product administered). No other adverse events were reported in the patient.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient requested to have the third dose of GARDASIL 9 about 10 months after the second dose; No additional AE; This spontaneous report was received from a pharmacist regarding a female patient of unknown age. No information about concurrent conditions, medical history or concomitant medications was given.   On an unknown date, the patient was vaccinated with the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot # and expiration date were not reported).  On an unknown date, the patient requested to have the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) about 10 months after the second dose. There were no other adverse event details available.
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus
Clinical narrative: sugar went to up to 140s; This case was reported by a physician via sales rep and described the occurrence of glucose increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes (Sugar was running in low 100's).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced glucose increased. On an unknown date, the outcome of the glucose increased was unknown.   It was unknown if the reporter considered the glucose increased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The week, the patient got shingrix her sugar went to up to 140s.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria, Rash, Rash vesicular
Clinical narrative: 2 hive like areas about 3 inches below site of injection; 2 hive like areas about 3 inches below site of injection that is painful to touch; blister type rash on torso; This case was reported by a other health professional via interactive digital media and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2020, the patient received the 1st dose of Shingrix. On 2nd December 2020, 3 days after receiving Shingrix, the patient experienced hives, pain and blistery rash. On an unknown date, the outcome of the hives, pain and blistery rash were unknown.   It was unknown if the reporter considered the hives, pain and blistery rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient received 1st dose of Shingrix 3 days ago from the date of reporting. At the time of reporting, the patient had 2 hive like areas about 3 inches below site of injection that was painful to touch.  The patient also had a blister type rash on torso.  The reporter asked, should he or she need to be concerned about being contagious in any way to his or her patients
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Still has pain; This case was reported by a consumer and described the occurrence of pain in a female 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 pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that he or she would be getting 2nd Shingles shot next week from the date of reporting and that was something he or she did not want.  Because the reporter watched his or her mother go through it and still had pain almost 2 years later.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash at the injection site; Red / at the injection site; This case was reported by a nurse and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were unknown.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed a red rash at the injection site after a dose of Shingrix.
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Swelling, Swelling face
Clinical narrative: swelling at the injection site; swelling / face; swelling / other parts of the body; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number YT5K7, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2020, the patient received Fluarix Tetra 2020-2021 season .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 1st December 2020, less than a day after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site swelling, facial swelling and swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling, facial swelling and swelling were unknown.   It was unknown if the reporter considered the injection site swelling, facial swelling and swelling to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Fluarix and within 3 hours after administration of the vaccine ended up going to the emergency room with swelling at the injection site as well as his face and other parts of the body. They gave him Benadryl in the emergency room and he responded fine.  The reporter stated that supposedly this patient never had a vaccine reaction in the past.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: little tired; sore; This case was reported by a consumer and described the occurrence of tiredness in a 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 a year after receiving Shingrix, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had shingles vaccine (Shingrix) earlier this year, the 1st shot was OK a little tired and sored. For 2nd dose tolerance refer case US2020AMR239668.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR239668:same patient, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix and experienced arm soreness For tolerance with 2nd dose refer case US2020242307. The reporter did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020242307:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Petechiae
Clinical narrative: first dose of Shingrix on 1/9/2020 / never received the second dose due to COVID-19 / / receiving first does / on 1/9/2020  and / second dose on 12/4/2020; pain and soreness at the site of injection; series of bumps along the spine  / under the skin / above the skin / base of the neck / continue down below the bra strap; bumps have a pink-ish hue that varies from day to day; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The patient never received the second dose due to COVID-19.  The reporter consented to follow up.   Follow up information was received from consumer on 5th January 2021: The patient received 2nd dose of Shingrix on 4th December 2020 and less than 2 months, the patient had pain and soreness at the site of injection. The reporter reported developing a series of bumps along the spine a day and a half after receiving 2nd dose of Shingrix. The patient stated that the bumps began under the skin and were currently above the skin. The bumps begin at the base of the neck and continue down below the bra strap and were in a straight line. The bumps were of the same or very similar size. The bumps had a pinkish hue that varies from day to day. The patient reported no pain associated with these bumps. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021001360:same patient, 1st dose
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z9H3, expiry date 7th October 2022) for prophylaxis.   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th December 2020, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The patient received the dose and shingles presented the next day. It was under her right breast and around her back on the right side. It was noted that the patient never had chicken pox. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: fever; nausea; This case was reported by a consumer and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received the 1st dose of Shingrix. On 15th December 2020, 1 days after receiving Shingrix, the patient experienced fever and nausea. On an unknown date, the outcome of the fever and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever and nausea to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's sister. The next day of receiving vaccine, the patient reported experiencing nausea and a fever. The reporter was asking for medical advice on how to treat the symptom and did not have time to do a report. The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache / ongoing; Fatigue / ongoing; Arm soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2020, the patient received Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On 21st December 2020, the patient experienced headache and fatigue. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the headache and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix dose and experienced arm soreness for a day or two after receiving the vaccine. The patient experienced headache and fatigue and ongoing till the time of report. The reporter did not consent to follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Incoherent, Pressure of speech, Psychiatric symptom
Clinical narrative: Psychiatric symptoms; Talking really fast; Not being with it, acting strange; Not coherent; A spontaneous report was received from a physician who was also a 34-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed psychiatric symptoms, talking really fast, acting strange, and incoherent.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 05 Jan 2021 in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, she experienced psychiatric symptoms. She started talking very fast, not being with it, acting strange, and incoherent. The symptoms got progressively worse by that evening and was taken to the emergency room. She was treated with an intramuscular antipsychotic and observed overnight.   On 07 Jan 2021, the patient was discharged from the hospital. Since she has been released from the hospital, she has been fine.   Action taken with mRNA-1273 in response to the events was not provided.   The events, psychiatric symptoms, talking really fast, acting strange, and incoherent, were considered resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of 34- year-old female patient who experienced serious unexpected events psychiatric symptoms, talking really fast, "not being with it," acting strange, and incoherent 13 hours after administration of mRNA-1273, lot # 026L20A, Exp date-unknown. Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait inability, Headache, Myalgia, Nausea
Clinical narrative: Collapsed; Unable to walk on her own; Muscle pain; Nausea; Vomiting; Headache at the base of her head and neck; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, collapsed, unable to walk on her own, muscle pain, nausea, vomiting, and headache at the base of her head and neck.   The patient's medical history, as provided by the reporter, included stroke.  No relevant concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 026L20A)  in the left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, after vaccine administration, the patient experienced a headache at the base of her head and neck.  On 03 Jan 2021, the patient collapsed and was unable to walk on her own.  She was hospitalized from 04 Jan 2021 to 05 Jan 2021. She also experienced muscle pain, nausea, and vomiting. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, collapsed, unable to walk on her own, muscle pain, nausea, vomiting, and headache at the base of her head and neck, was unknown.; Reporter's Comments: This case concerns a 72 year old, female patient with a history of stroke, who experienced a serious unexpected event of fall, gait inability and non-serious expected event of myalgia, nausea, vomiting and headache. The event of headache occurred same day after first dose mRNA-1273 (Lot# 026L20A) administration. The event of fall and gait inability occurred 5 days after first dose of mRNA-1273. The event of myalgia, nausea, vomiting occurred on an unspecified date after mRNA-1273 (Lot# 026L20A) administration. The treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Collapsed; Unable to walk on her own; Muscle pain; Nausea; Vomiting; Headache at the base of her head and neck; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, collapsed, unable to walk on her own, muscle pain, nausea, vomiting, and headache at the base of her head and neck.   The patient's medical history, as provided by the reporter, included stroke.  No relevant concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 026L20A)  in the left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, after vaccine administration, the patient experienced a headache at the base of her head and neck.  On 03 Jan 2021, the patient collapsed and was unable to walk on her own.  She was hospitalized from 04 Jan 2021 to 05 Jan 2021. She also experienced muscle pain, nausea, and vomiting. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, collapsed, unable to walk on her own, muscle pain, nausea, vomiting, and headache at the base of her head and neck, was unknown.; Reporter's Comments: This case concerns a 72 year old, female patient with a history of stroke, who experienced a serious unexpected event of fall, gait inability and non-serious expected event of myalgia, nausea, vomiting and headache. The event of headache occurred same day after first dose mRNA-1273 (Lot# 026L20A) administration. The event of fall and gait inability occurred 5 days after first dose of mRNA-1273. The event of myalgia, nausea, vomiting occurred on an unspecified date after mRNA-1273 (Lot# 026L20A) administration. The treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Pruritus, Urticaria
Clinical narrative: Cellulitis at middle arm and not on deltoid; Redness which is 3in in size; Itching; Hives; A spontaneous report was received from a nurse concerning a  27-year old, female patient who received Moderna's COVID-19 vaccine and experienced cellulitis at middle arm and not on deltoid, redness which is 3in in size, itching, and hives.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the patient experienced redness which is 3in in size, itching, and what the patient described as hives. The patient went to urgent care where she was diagnosed with cellulitis at middle arm and not on deltoid. Treatment for the events included antibiotic and loratadine.   Action taken with mRNA-1273 in response to the events was unknown.  The events cellulitis at middle arm and not on deltoid, redness which is 3in in size, itching, and hives were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 27 year old, female patient, who experienced a serious unexpected event of cellulitis; non-serious unexpected event of pruritus and urticaria and a non-serious expected event of erythema. The event of cellulitis, erythema, pruritus, and urticaria occurred 11 days after first dose mRNA-1273 (Lot# 025J20-2A) administration. The treatment medications included Claritin and antibiotics. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Hemiplegia, Pruritus, Urticaria
Clinical narrative: Intermittent paralyzed left side; Hives; itching; Redness; Shortness of breath; A spontaneous report was received from a nurse who was also a 70-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed left sided paralysis, shortness of breath, hives, itching, and redness.  The patient's medical history included asthma. Products known to have been used by the patient, within two weeks prior to the event, included albuterol sulfate, epinephrine and diphenhydramine.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 075T202A) intramuscularly for prophylaxis of COVID-19 infection.     On 05 Jan 2021, after receiving the vaccine the patient developed redness, itching and shortness of breath. On 06 Jan 2021, she developed hives and was paralyzed after sleeping. She experienced paralysis on the left side and her right side felt heavy. Treatment for the events included diphenhydramine, epinephrine, and albuterol.  Action taken with the second dose of mRNA-1273 in response to the events was not provided.    The events, paralysis on the left side and hives, was considered resolved on 07 Jan 2021. The events, redness, itching and shortness of breath, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 70 year old, female patient, with a medical history of asthma, who experienced a serious unexpected event of hemiplegia, a non-serious unexpected event of dyspnoea, urticaria, pruritus and a non-serious expected event of erythema. The event of dyspnoea, pruritus, and erythema occurred 1 day after first dose mRNA-1273 (Lot# 075T202A) administration. The event of hemiplegia and urticaria occurred 3 days after first dose mRNA-1273 (Lot# 075T202A) administration. Both concomitant and treatment medications included Benadryl, Primatene mist and albuterol. 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: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted.   The patient's medical history included diabetes, cholesterol, hypertension, and osteoporosis. Concomitant product use reported included unspecified medications for diabetes, cholesterol, high blood pressure, and osteoporosis.   On 08 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: VW7392) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient fainted at 3:00 am and again at 7:00 pm. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported .   The outcome for the event, fainting, was not reported.; Reporter's Comments: This case concerns a 79 year old female subject, with medical history of diabetes, cholesterol and hypertension, who experienced a serious unlisted event of syncope.   The event occurred 3 days after the first dose of mRNA-1273. 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.  However a definitive assessment is confounded by the patient's history of diabetes and hypertension.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Dizziness, Limb discomfort
Clinical narrative: Lost consciousness for about 5 minutes; Couldn't move her leg; Started feeling lightheaded, dizzy; Body started feeling weak; Right arm started shaking; Left leg felt very heavy; Couldn't wiggle her toes; A spontaneous report  was received from a consumer concerning a 66-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced feeling lightheaded, dizzy, body started feeling weak. Right arm started shaking, lost consciousness for about 5 minutes. Her left leg felt very heavy and couldn't move her leg or wiggle her toes.  Concomitant product use was not provided by the reporter.  On 07 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   After patient got the vaccine, she drank some water because she was lightheaded and dizzy. She was offered crackers by the nurse. After her body started shaking, a nurse wheeled her to the emergency room. Her computerized tomogram scan on her head and magnetic resonance imaging of back came back normal. Blood tests were normal.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, lost consciousness was considered recovered/resolved on 07 Jan 2021. The events left leg felt very heavy and couldn't move it and couldn't wiggle her toes were considered recovered/resolved on 11 Jan 2021. The outcome of the events, lightheaded, body started feeling weak and right arm started shaking was not reported.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the serious unlisted events of Loss of consciousness and Monoplegia and non-serious unlisted events of Dizziness, Asthenia, Tremor, Limb discomfort, and Musculoskeletal disorder.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging, Monoplegia, Musculoskeletal disorder, Tremor
Clinical narrative: Lost consciousness for about 5 minutes; Couldn't move her leg; Started feeling lightheaded, dizzy; Body started feeling weak; Right arm started shaking; Left leg felt very heavy; Couldn't wiggle her toes; A spontaneous report  was received from a consumer concerning a 66-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced feeling lightheaded, dizzy, body started feeling weak. Right arm started shaking, lost consciousness for about 5 minutes. Her left leg felt very heavy and couldn't move her leg or wiggle her toes.  Concomitant product use was not provided by the reporter.  On 07 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   After patient got the vaccine, she drank some water because she was lightheaded and dizzy. She was offered crackers by the nurse. After her body started shaking, a nurse wheeled her to the emergency room. Her computerized tomogram scan on her head and magnetic resonance imaging of back came back normal. Blood tests were normal.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, lost consciousness was considered recovered/resolved on 07 Jan 2021. The events left leg felt very heavy and couldn't move it and couldn't wiggle her toes were considered recovered/resolved on 11 Jan 2021. The outcome of the events, lightheaded, body started feeling weak and right arm started shaking was not reported.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the serious unlisted events of Loss of consciousness and Monoplegia and non-serious unlisted events of Dizziness, Asthenia, Tremor, Limb discomfort, and Musculoskeletal disorder.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Contusion, Musculoskeletal stiffness, Nodule, Numb chin syndrome
Clinical narrative: Face and chin numb for two days; Stiffness; Stiffness around the collar bone; Pain on left side; Swelling around the collar bone; Pea sized lump; Black and blue on left side; Tender at collar bone and shoulder; A spontaneous report was received from a consumer concerning a 34-year old, male patient who received Moderna's COVID-19 vaccine and experienced swelling, stiffness around the collar bone, pain on the left side, a pea-sized lump, face and chin numbness, black and blue skin on the left side, and tenderness at the collar bone and shoulder.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 6 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient reported that he experienced swelling and stiffness around his collar bone, a pea-sized lump, pain on his left side and face and chin numbness for 2 days. Most symptoms resided at time of report, but the patient was still black and blue on the left side and tender at his collar bone and shoulder.  Treatment for the event included heating pad and paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The event, face and chin numbness, was considered recovered/resolved on 07 Jan 2021. The events, swelling, stiffness around the collar bone, pain on the left side, a pea-sized lump, was considered resolved on an unknown date.The events, black and blue skin on the left side and tenderness at the collar bone and shoulder, were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 34-year old, male patient, who experienced a serious unexpected event of numb chin syndrome, and non-serious unexpected event of musculoskeletal stiffness, pain, swelling, nodule, contusion, and tenderness. The events occurred 7 days after first dose of mRNA-1273, lot # 026L20A. Treatment included Tylenol and heating pad. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Face and chin numb for two days; Stiffness; Stiffness around the collar bone; Pain on left side; Swelling around the collar bone; Pea sized lump; Black and blue on left side; Tender at collar bone and shoulder; A spontaneous report was received from a consumer concerning a 34-year old, male patient who received Moderna's COVID-19 vaccine and experienced swelling, stiffness around the collar bone, pain on the left side, a pea-sized lump, face and chin numbness, black and blue skin on the left side, and tenderness at the collar bone and shoulder.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately 6 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient reported that he experienced swelling and stiffness around his collar bone, a pea-sized lump, pain on his left side and face and chin numbness for 2 days. Most symptoms resided at time of report, but the patient was still black and blue on the left side and tender at his collar bone and shoulder.  Treatment for the event included heating pad and paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The event, face and chin numbness, was considered recovered/resolved on 07 Jan 2021. The events, swelling, stiffness around the collar bone, pain on the left side, a pea-sized lump, was considered resolved on an unknown date.The events, black and blue skin on the left side and tenderness at the collar bone and shoulder, were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 34-year old, male patient, who experienced a serious unexpected event of numb chin syndrome, and non-serious unexpected event of musculoskeletal stiffness, pain, swelling, nodule, contusion, and tenderness. The events occurred 7 days after first dose of mRNA-1273, lot # 026L20A. Treatment included Tylenol and heating pad. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tonsillitis
Clinical narrative: Tonsillitis; A spontaneous report was received from a female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced tonsillitis.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On an undisclosed date, the patient experienced tonsillitis. Treatment for the event included antibiotics.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, tonsillitis, was considered unknown.; Reporter's Comments: event of tonsillitis occurred on an unspecified date after the first dose of mRNA-1273 (lot # unknown) administration. She was treated with antibiotics (details not provided. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Tachycardia
Clinical narrative: Atrial Fibrillation; Tachycardia (Double heart rate); A spontaneous report was received from a 73-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced atrial fibrillation and tachycardia.   The patient's medical history was not provided No relevant concomitant medications were reported.   On 09 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10 Jan 2021, the patient reported having atrial fibrillation and tachycardia. Treatment for the events included metoprolol.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, atrial fibrillation and tachycardia, were considered not resolved.; Reporter's Comments: This case concerns a 73-year-old, female patient. The patient's medical history was not provided. The patient experienced an unexpected event of Atrial fibrillation and tachycardia. The event occurred 2 days after the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Intercepted medication error
Clinical narrative: Second dose scheduled 42 days later; A spontaneous report was received from a 56-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and had second dose Moderna COVID-19 vaccine scheduled for 42 days later.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   After receiving the first vaccine on 05 Jan 2021, the second appointment was canceled so the computer system made her another appointment for her second Moderna Covid-19 vaccine on 16 Feb 2021 which is 42 days later and not within the recommended timeline. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, had second dose Moderna COVID-19 vaccine scheduled for 42 days later, was considered resolved.; Reporter's Comments: This report refers to a case of intercepted medication error for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of intercepted medication error.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Limb discomfort, Product administration error, Pruritus
Clinical narrative: Looked like cellulitis; Redness had spread; Painful; Itchy; Arm became really hard and swollen; Dose above deltoid; A spontaneous report was received from a consumer concerning a 25-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed hard and swelling, itchiness, redness and pain at the injection site which resembled cellulitis, and she received the vaccine in the wrong anatomical location.   The patient's medical history and relevant concomitant medications were not reported.   On 04 Jan 2021, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the upper shoulder joint for prophylaxis of COVID-19 infection.   On 11 Jan 2021 the patient's arm became hard, swollen, itchy, and painful.    On 12 Jan 2021 the patient's arm was red and resembled cellulitis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, she received the vaccine in the wrong anatomical location, was resolved on 04 Jan 2021. The outcome of the event itchiness resolved on 12 Jan 2021. The outcome of the events swelling and pain at the injection site which resembled cellulitis were not reported..; Reporter's Comments: This case concerns a 25 years old female patient, who experienced product administration error, and a non-serious unexpected event of limb discomfort, vaccination site cellulitis, and non-serious expected event of pruritus, pain and redness. There were no reported AEs associated with this case of product administration error. The events of limb discomfort, pruritus, and pain occurred 8 days after first dose of mRNA-1273, lot # unknown. The event of erythema, and vaccination site cellulitis occurred 9 days after first dose of mRNA-1273, lot # unknown. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events (vaccination site cellulitis, pruritus, limb discomfort, pain and redness) a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: Looked like cellulitis; Redness had spread; Painful; Itchy; Arm became really hard and swollen; Dose above deltoid; A spontaneous report was received from a consumer concerning a 25-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed hard and swelling, itchiness, redness and pain at the injection site which resembled cellulitis, and she received the vaccine in the wrong anatomical location.   The patient's medical history and relevant concomitant medications were not reported.   On 04 Jan 2021, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the upper shoulder joint for prophylaxis of COVID-19 infection.   On 11 Jan 2021 the patient's arm became hard, swollen, itchy, and painful.    On 12 Jan 2021 the patient's arm was red and resembled cellulitis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, she received the vaccine in the wrong anatomical location, was resolved on 04 Jan 2021. The outcome of the event itchiness resolved on 12 Jan 2021. The outcome of the events swelling and pain at the injection site which resembled cellulitis were not reported..; Reporter's Comments: This case concerns a 25 years old female patient, who experienced product administration error, and a non-serious unexpected event of limb discomfort, vaccination site cellulitis, and non-serious expected event of pruritus, pain and redness. There were no reported AEs associated with this case of product administration error. The events of limb discomfort, pruritus, and pain occurred 8 days after first dose of mRNA-1273, lot # unknown. The event of erythema, and vaccination site cellulitis occurred 9 days after first dose of mRNA-1273, lot # unknown. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events (vaccination site cellulitis, pruritus, limb discomfort, pain and redness) a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Arm soreness; vaccine was not administered in the deltoid muscle - it was 4 or 5 inches lower on arm; A spontaneous report/solicited was received from a 53-year-old female nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine was not administered in the deltoid muscle, it was 4 or 5 inches lower on arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the arm for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient reports that the vaccine was not administered in the deltoid muscle, it was 4 or 5 inches lower on arm. It was unknown if the vaccine was given intramuscularly. The patient also experienced arm soreness. No treatment was rendered for the event.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, vaccine was not administered in the deltoid muscle, it was 4 or 5 inches lower on arm, was considered resolved on 09 Jan 2021. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 53-year old female patient who experienced an unexpected non-serious event of Pain in extremity after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Additionally, the patient had Product administered at inappropriate site. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.