chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dyspnoea, Electrocardiogram normal, Hypoaesthesia, Seizure
Clinical narrative: Difficulty breathing, numbness in arm, and mild seizure working 5 minutes of receiving vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Seizure
Clinical narrative: Difficulty breathing, numbness in arm, and mild seizure working 5 minutes of receiving vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Difficulty breathing, numbness in arm, and mild seizure working 5 minutes of receiving vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Difficulty breathing, numbness in arm, and mild seizure working 5 minutes of receiving vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Premature delivery, Premature rupture of membranes
Clinical narrative: Due date: May 14, 2021 My water broke less than 24 hours after my second dose of the Pfizer vaccination. I started leaking amniotic fluid in the morning of 4/17/21 and went to the hospital around 1 pm the same day. It was diagnosed as Premature Rupture of Membranes and my son was delivered on 4/18/21.  Birth weight was 6 lbs, 14 ounces.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Lip swelling
Clinical narrative: Severe rigors,  fever,  malaise, extreme generalized weakness,  lip and tongue swelling,  generalized skin rash with itching,  shortness of breath,  dizziness,  presyncope, tachycardia.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Presyncope, Pruritus, Pyrexia, Rash
Clinical narrative: Severe rigors,  fever,  malaise, extreme generalized weakness,  lip and tongue swelling,  generalized skin rash with itching,  shortness of breath,  dizziness,  presyncope, tachycardia.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tachycardia
Clinical narrative: Severe rigors,  fever,  malaise, extreme generalized weakness,  lip and tongue swelling,  generalized skin rash with itching,  shortness of breath,  dizziness,  presyncope, tachycardia.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Truncus arteriosus persistent
Clinical narrative: Persistent truncus arteriosus
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Chest pain and heart feels like its pounding. Been going on for a few days without feeling of getting better. Have scheduled an appointment with doctor about this.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain in extremity, Palpitations
Clinical narrative: Heart Palpitations,  arm pain, swollen lymph nodes in arm injection was given, headache, chills
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Aches from top of my head to toes, headache,  fever,  swollen lymph nodes under right arm.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Paraesthesia, Skin irritation
Clinical narrative: Within 15 minutes of shot I had tingling in my feet and up my leg on left side.  Tingling/nerve irritation continued on and off for 10 days now and moves around to different parts of my body, especially hands, fingers, arms below elbow, cheek to chin area on face, and front and back of calves on both legs.  75% of day I feel this tingling somewhere on my skin.  Sometimes it also has a light burning sensation.  Today is day 10 after shot and the tingling is still moving around but becoming less intense in terms of the amount of skin it is irritating.  Seems to be smaller bands of irritation now.  Overall, not knowing if these symptoms would go away and getting increasing worse each day until today caused me anxiety about the vaccine, especially because I did not experience this with the 1st or 2nd Pfizer dose.  After this experience I will refuse other future COViD vaccinations.  This side effect is miserable and worrisome for a healthy person.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Chills, Cough, Decreased appetite, Diarrhoea
Clinical narrative: Chills, fatigue, dizziness when standing, nose bleeds, cough, hand tremors, cold hands & feet, heart palpitations, brain fog, decreased appetite, loose bowels, putrid bowels. Insomnia, heavy legs, dry rash on face, head arm & legs. Bleed out huge clots from vomiting although he has no clotting g factor from liver damage
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural, Epistaxis, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: Chills, fatigue, dizziness when standing, nose bleeds, cough, hand tremors, cold hands & feet, heart palpitations, brain fog, decreased appetite, loose bowels, putrid bowels. Insomnia, heavy legs, dry rash on face, head arm & legs. Bleed out huge clots from vomiting although he has no clotting g factor from liver damage
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Palpitations, Peripheral coldness, Rash, Thrombosis
Clinical narrative: Chills, fatigue, dizziness when standing, nose bleeds, cough, hand tremors, cold hands & feet, heart palpitations, brain fog, decreased appetite, loose bowels, putrid bowels. Insomnia, heavy legs, dry rash on face, head arm & legs. Bleed out huge clots from vomiting although he has no clotting g factor from liver damage
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Chills, fatigue, dizziness when standing, nose bleeds, cough, hand tremors, cold hands & feet, heart palpitations, brain fog, decreased appetite, loose bowels, putrid bowels. Insomnia, heavy legs, dry rash on face, head arm & legs. Bleed out huge clots from vomiting although he has no clotting g factor from liver damage
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abnormal faeces, Diarrhoea, Flatulence, Pyrexia
Clinical narrative: Horrible diarrhea and upset stomach with smelly bowel movements and painful gas to start. Then I started running a 101 degree fever for about 28 hours after that. I continue to have a sharp pain in my left side which feels like gas as I continue to pass really smelly gas.  FYI?I received the Moderna 2 dose vaccine in the spring with no fever and no GI issues with either dose.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Blood thyroid stimulating hormone, Cardiac monitoring, Chest X-ray, Electrocardiogram
Clinical narrative: I had had several nights where I would be completely at rest for several hours when my heart rate would race between 90-95 bpm for an hour or more. Then, on October 12, 2021 my heart rate was between 100-120+ bpm for over an hour and would not go down. Living alone, I did not feel safe driving myself, so I called 911 and went by ambulance. There were no explanations found while at the Emergency Room, but I continued to have those high heart rates. I did go see a cardiologist as well, and nothing was found again.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Full blood count, Heart rate increased, Metabolic function test, Palpitations
Clinical narrative: I had had several nights where I would be completely at rest for several hours when my heart rate would race between 90-95 bpm for an hour or more. Then, on October 12, 2021 my heart rate was between 100-120+ bpm for over an hour and would not go down. Living alone, I did not feel safe driving myself, so I called 911 and went by ambulance. There were no explanations found while at the Emergency Room, but I continued to have those high heart rates. I did go see a cardiologist as well, and nothing was found again.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Troponin I, Ultrasound Doppler
Clinical narrative: I had had several nights where I would be completely at rest for several hours when my heart rate would race between 90-95 bpm for an hour or more. Then, on October 12, 2021 my heart rate was between 100-120+ bpm for over an hour and would not go down. Living alone, I did not feel safe driving myself, so I called 911 and went by ambulance. There were no explanations found while at the Emergency Room, but I continued to have those high heart rates. I did go see a cardiologist as well, and nothing was found again.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Pruritus, Rash, Scratch
Clinical narrative: My left arm was very sore just near the shot site.  It became itchy later that night or the next morning.  After scratching, a small rash appeared and stayed. It's smaller today but still there.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: I have had a mild burning sensation on my tongue not long after receiving the 1st dose of my Moderna Vaccine. The symptoms are rather annoying and have not subsided or worsened even after receiving the 2nd dose of my Moderna Vaccine.   Researching my issue it would look to be best described as "idiopathic glossopyrosis"
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Chills, Headache, Pain
Clinical narrative: After the chills and aches (headache and body) my blood sugar level has elevated to upwards of 400 consistently every day since 12/1/2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Peripheral swelling, Tenderness
Clinical narrative: I receive Botox injections in both under arms to treat severe auxiliary hyperhydrosis. After my booster both armpits got very swollen (no rash) and felt as if the tissue had an excess of fluid trapped in the tissue. Both armpits were swollen (injection side -right was more swollen) and were painful to touch).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Demyelination, Hypoaesthesia, Magnetic resonance imaging abnormal, Multiple sclerosis, Myelopathy
Clinical narrative: 3 months after my second shot I started to feel the effects of Multiple Sclerosis
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paraesthesia
Clinical narrative: 3 months after my second shot I started to feel the effects of Multiple Sclerosis
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe bilateral knee joint pain without previous injury
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Substantial pain and swelling of lymph nodes underneath both arms. Pain and swelling began within 24 hours of receiving vaccine and subsided after 5 days. Took ibuprofen (1200 mg/day) to manage symptoms.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not provided. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # T040207, expiration date: 18-JUL-2022, oral for prophylaxis (dose, frequency, route of administration and anatomical location were not provided). On 23-DEC-2021, the doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) had a temperature excursion (product storage error) of 27.4 degree Celsius for 52 hours and 30 minutes. There was no previous temperature excursion.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th December 2021, 2 hrs after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 30th December 2021, the patient experienced injection site pain and injection site erythema. In December 2021, the outcome of the injection site erythema and injection site pain were recovered/resolved. On 1st January 2022, the outcome of the injection site pain and injection site erythema were recovered/resolved.   The reporter considered the injection site erythema, injection site pain, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient received her first Shingrix vaccine in her left arm and about 2 hours after the Shingrix injection she began to feel redness/soreness at the injection site.  Her left arm was very sore and redder the next day but resolved in 3 days.  The reporter said, redness/soreness reoccurred on 30th December 2021 at the injection site. 6 days after receiving Shingrix, the redness/soreness reoccurred at the injection site. The redness/soreness resolved on 1st January 2022.   The reporter said, her arm was fine right now on 3rd January 2022. The reporter did not give permission to contact healthcare professional. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR000933:Same reporter.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Ear pruritus, Ear swelling, Erythema, Hypersensitivity, Lip pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hypersensitivity reaction in a adult female patient who received Herpes zoster (shingrix) for prophylaxis.  Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis. On an unknown date, the patient received the 1st dose of shingrix and PNEUMONIA VACCINE. On an unknown date, 1 day after receiving shingrix, the patient experienced hypersensitivity reaction, lip pruritus, red face, skin blotches, ear pruritus and ear swelling. The patient was treated with ambiguous medication nos (Epipen (Nos)). On an unknown date, the outcome of the hypersensitivity reaction, lip pruritus, red face, skin blotches, ear pruritus and ear swelling were recovered/resolved.  It was unknown if the reporter considered the hypersensitivity reaction, lip pruritus, red face, skin blotches, ear pruritus and ear swelling to be related to shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. In 2019, the patient received first dose of shingrix and on the same day patient received Pneumonia vaccine. The patient stated the next morning after receiving the shingrix and Pneumonia vaccine, she began experiencing symptoms that included itching of both lips, redness of the face, blotchy patches on the face, and itching and swelling of both ears. The patient reached out to the healthcare professional (HCP) that administered the vaccine and was advised to come into the office immediately. At the office the patient was administered EpiPen and waited in the office for approximately 1 hour, for observation. 1 day after vaccinations, the healthcare professional stated that the patient had experienced a hypersensitivity reaction to the vaccine and was advised to not proceed with the second dose. The reporter considered the lip pruritus, red face, blotchy, ear pruritus, ear swelling and hypersensitivity to be related to Pneumonia vaccine. The reporter consented to follow up.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hypersensitivity reaction in a adult female patient who received Herpes zoster (shingrix) for prophylaxis.  Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis. On an unknown date, the patient received the 1st dose of shingrix and PNEUMONIA VACCINE. On an unknown date, 1 day after receiving shingrix, the patient experienced hypersensitivity reaction, lip pruritus, red face, skin blotches, ear pruritus and ear swelling. The patient was treated with ambiguous medication nos (Epipen (Nos)). On an unknown date, the outcome of the hypersensitivity reaction, lip pruritus, red face, skin blotches, ear pruritus and ear swelling were recovered/resolved.  It was unknown if the reporter considered the hypersensitivity reaction, lip pruritus, red face, skin blotches, ear pruritus and ear swelling to be related to shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. In 2019, the patient received first dose of shingrix and on the same day patient received Pneumonia vaccine. The patient stated the next morning after receiving the shingrix and Pneumonia vaccine, she began experiencing symptoms that included itching of both lips, redness of the face, blotchy patches on the face, and itching and swelling of both ears. The patient reached out to the healthcare professional (HCP) that administered the vaccine and was advised to come into the office immediately. At the office the patient was administered EpiPen and waited in the office for approximately 1 hour, for observation. 1 day after vaccinations, the healthcare professional stated that the patient had experienced a hypersensitivity reaction to the vaccine and was advised to not proceed with the second dose. The reporter considered the lip pruritus, red face, blotchy, ear pruritus, ear swelling and hypersensitivity to be related to Pneumonia vaccine. The reporter consented to follow up.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Rotarix reconstituted with sterile water; Rotarix reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 5th January 2022, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 5th January 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional called regarding a patient of unknown age and gender and reported that the patient orally received Rotarix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. At the time of call, the reporter did not had any information of the patient's demographics available.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF A DOSE OF THE VACCINE 6 HOURS AND 20 MINUTES AFTER FIRST PUNCTURE OF THE VIAL; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191,expiry: UNKNOWN) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 06-JAN-2022, the patient experienced administration of a dose of the vaccine 6 hours and 20 minutes after first puncture of the vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of a dose of the vaccine 6 hours and 20 minutes after first puncture of the vial was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Body aches; chills; slight fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (chills) and FATIGUE (slight fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced MYALGIA (Body aches), CHILLS (chills) and FATIGUE (slight fatigue). At the time of the report, MYALGIA (Body aches), CHILLS (chills) and FATIGUE (slight fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2022-443029 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, Nasal congestion, Nasal discharge discolouration
Clinical narrative: stuffy nose, nose is stuffy and no.matter how much i blow it it still clogs back up with nasty green snot.; I cant smell very good at all but i can still taste some bit; Nasty green snot; This spontaneous case was reported by an other health care professional and describes the occurrence of NASAL CONGESTION (stuffy nose, nose is stuffy and no.matter how much i blow it it still clogs back up with nasty green snot.), ANOSMIA (I cant smell very good at all but i can still taste some bit) and NASAL DISCHARGE DISCOLOURATION (Nasty green snot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (stuffy nose, nose is stuffy and no.matter how much i blow it it still clogs back up with nasty green snot.), ANOSMIA (I cant smell very good at all but i can still taste some bit) and NASAL DISCHARGE DISCOLOURATION (Nasty green snot). At the time of the report, NASAL CONGESTION (stuffy nose, nose is stuffy and no.matter how much i blow it it still clogs back up with nasty green snot.), ANOSMIA (I cant smell very good at all but i can still taste some bit) and NASAL DISCHARGE DISCOLOURATION (Nasty green snot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter  Company Comment  This case concerns a patient of an unknown age and gender with no reported medical history, who experienced the non-serious unexpected AESI of Anosmia. The event occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no reported medical history, who experienced the non-serious unexpected AESI of Anosmia. The event occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: petechiae again petechiae again on shins on the skin, not in the upper thigh, just the lower legs/ its on both legs; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (petechiae again petechiae again on shins on the skin, not in the upper thigh, just the lower legs/ its on both legs) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 046821A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced PETECHIAE (petechiae again petechiae again on shins on the skin, not in the upper thigh, just the lower legs/ its on both legs). At the time of the report, PETECHIAE (petechiae again petechiae again on shins on the skin, not in the upper thigh, just the lower legs/ its on both legs) had not resolved.            Concomitant medications were not provided.  Treatment information was not provided.  Patient had petechiae on both legs.  Company Comment: This case concerns a 49-year-old female patient, with no medical history reported, who experienced the unexpected event of Petechiae. The event occurred on the same day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was not resolved. The rechallenge is positive since the same event recurred upon re-administration of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-407943 (Patient Link).; Sender's Comments: This case concerns a 49-year-old female patient, with no medical history reported, who experienced the unexpected event of Petechiae. The event occurred on the same day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was not resolved. The rechallenge is positive since the same event recurred upon re-administration of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatologic examination, Pruritus, Urticaria
Clinical narrative: Chronic hives began around 2-3 weeks after the Moderna booster shot.  It started as localized hives/itching in feet, palms of hands, groin area, under breasts.  It developed into itching and hives all over my body (arms, legs, scalp, back, abdomen, etc).  It has persisted daily since it began.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site pain, Paraesthesia
Clinical narrative: Lightheaded, head spinning effect like vertigo (4th day) , site pain, chills, skin sensitivity like pinching with needles, fever for two days, super heavy headache.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin, Vertigo
Clinical narrative: Lightheaded, head spinning effect like vertigo (4th day) , site pain, chills, skin sensitivity like pinching with needles, fever for two days, super heavy headache.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Erythema, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: dermatographia; hives; itching; redness in different part of body/ it starts in one part and then it moves to different area; full dose instead of booster; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (dermatographia), URTICARIA (hives), PRURITUS (itching), ERYTHEMA (redness in different part of body/ it starts in one part and then it moves to different area) and ACCIDENTAL OVERDOSE (full dose instead of booster) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A, 012L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (full dose instead of booster). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographia), URTICARIA (hives), PRURITUS (itching) and ERYTHEMA (redness in different part of body/ it starts in one part and then it moves to different area). On 22-Sep-2021, ACCIDENTAL OVERDOSE (full dose instead of booster) had resolved. At the time of the report, MECHANICAL URTICARIA (dermatographia), URTICARIA (hives), PRURITUS (itching) and ERYTHEMA (redness in different part of body/ it starts in one part and then it moves to different area) outcome was unknown.            No concomitant medications were reported.  It was reported that  few weeks after getting third dose, she started developing skin condition which was later diagnosed with dermatologist as" dermatographia",  It was reported that patient at the time she was travelling and booster shot was not available so she took full dose instead. Patient had no allergy or change in diet. Patient had has upcoming visit with allergist.  No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of headache (slight headache that went away) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. In January 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In January 2021, patient experienced headache (slight headache that went away). At the time of the report, headache (slight headache that went away): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received the 1st dose of Moderna COVID-19 vaccine on last week of Jan 2021. She had experienced slight headache that went away. Patient's dose given at a local healthcare facility. This case linked to MOD-2022-440584 (patient link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (Developed hives). At the time of the report, URTICARIA (Developed hives) was resolving.            Concomitant information was not provided.  Treatment information included antihistamine, which helps clear the hives.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired for 24 hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008F21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired for 24 hours). In December 2021, FATIGUE (Tired for 24 hours) had resolved.            Concomitant product information was not provided Treatment information was not provided   This case was linked to MOD-2022-441862, MOD-2022-441948 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Follow up received and contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: After receiving the vaccine I didn't feel like doing something; After receiving the vaccine I felt tired; I had a headache; I had body aches; I had nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (After receiving the vaccine I didn't feel like doing something), FATIGUE (After receiving the vaccine I felt tired), HEADACHE (I had a headache), MYALGIA (I had body aches) and NAUSEA (I had nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced FEELING ABNORMAL (After receiving the vaccine I didn't feel like doing something), FATIGUE (After receiving the vaccine I felt tired), HEADACHE (I had a headache), MYALGIA (I had body aches) and NAUSEA (I had nausea). At the time of the report, FEELING ABNORMAL (After receiving the vaccine I didn't feel like doing something), FATIGUE (After receiving the vaccine I felt tired), HEADACHE (I had a headache), MYALGIA (I had body aches) and NAUSEA (I had nausea) outcome was unknown.            No Concomitant Medications were provided. No Treatment Medications were provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness
Clinical narrative: Patient got sick for 2 days; Felt very tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient got sick for 2 days), FATIGUE (Felt very tired) and CHILLS (Chills) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced ILLNESS (Patient got sick for 2 days), FATIGUE (Felt very tired) and CHILLS (Chills). At the time of the report, ILLNESS (Patient got sick for 2 days) had resolved and FATIGUE (Felt very tired) and CHILLS (Chills) outcome was unknown.            No concomitant medication details were provided.  No treatment medication details were provided.   This case was linked to MOD-2022-440621, MOD-2022-440667 (Patient Link).
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: The last time patient had the flu was when patient last got a flu shot sometime before 1980; Initial information received on 01-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves unknown gender and age patient who stated the last time patient had the flu was when patient last got a flu shot sometime before 1980 while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported; formulation: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "the last time patient had the flu was when patient last got a flu shot sometime before 1980" (influenza) (unknown latency).  It is unknown if there were lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event the last time patient had the flu was when patient last got a flu shot sometime before 1980.
Sex: U
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: every joint in my body ached; Initial information received on 30-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics who reported every joint in his/her  body ached while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date was unknown) for Flu vaccination.  On an unknown date the patient developed a non-serious event "every joint in my body ached" (arthralgia) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (every joint in my body ached).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event every joint in my body ached.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Headache, fever, chills, body aches, sore arm. Injection site was sore but want red but today Jan 10 when I woke up it was lightly pink and slightly swollen.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, fever, chills, body aches, sore arm. Injection site was sore but want red but today Jan 10 when I woke up it was lightly pink and slightly swollen.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hypersensitivity, Pruritus, Scratch, Stress
Clinical narrative: About a week after I have developed chronic non stop itching. It?s extreme to the point I scratch until I have bruises and sores. I started taking Zyrtec to help (thinking it was allergies and/or stress) daily. It goes away after taking Zyrtec but pops back up in the afternoon daily so I take two. The need for multiple doses is because I had gastric bypass in 2009, so medications run through me quickly. I take great care of my skin and no changes to products. I have reported it to multiple doctors and was thought to be stress. I?m currently in a halfway house and explained to nursing that ever since this second vaccine I have to take it. I thought my immune system was in protest (I have RA and had Covid twice.) The nurse didn?t think I was crazy and told me I?m not the first person who said this of the Moderna shot and said it could be an allergic reaction. Makes soo much sense to me.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2108USA003026), concerning an currently 73-year-old male patient. Since an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (manufacture unknown) injection yearly for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration). The patient didn't have any adverse reactions. This is one of two reports regarding the same patient.; Sender's Comments: US-009507513-2108USA003026.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 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, unknown after receiving shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The case was reported by reporter for his/her doctor. The age at vaccination was not applicable for this report. The reporter reported that till the time of reporting, the patient never received the second shingrix vaccine which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available. This case had been linked to the case US2022AMR003234, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR003234:same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 21st June 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if he/she still could get the second shot even though it had been just beyond six months since the first one. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Drug ineffective, Herpes zoster, Seizure, Speech disorder
Clinical narrative: Worsening of seizures; "Speech getting worse"; 2nd dose Jan2021, Dec2021 shingles/suspected Vaccination failure; Shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 21st December 2021, 11 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced convulsions aggravated (serious criteria GSK medically significant) and speech disorder. On an unknown date, the outcome of the vaccination failure, convulsions aggravated, shingles and speech disorder were unknown.   It was unknown if the reporter considered the vaccination failure, convulsions aggravated, shingles and speech disorder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 2nd dose of Shingrix in January 2021 and she was with shingles outbreak (lack of drug effect). Less than 2 years after receiving vaccination, the patient had worsening of her seizures and that her speech was getting worse. The patient provided very limited information and refused to provide demographics or answer questions related to adverse event.   No further information or details were provided by the caller. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation were unknown at the time of reporting. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Worsening of seizures; "Speech getting worse"; 2nd dose Jan2021, Dec2021 shingles/suspected Vaccination failure; Shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 21st December 2021, 11 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced convulsions aggravated (serious criteria GSK medically significant) and speech disorder. On an unknown date, the outcome of the vaccination failure, convulsions aggravated, shingles and speech disorder were unknown.   It was unknown if the reporter considered the vaccination failure, convulsions aggravated, shingles and speech disorder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 2nd dose of Shingrix in January 2021 and she was with shingles outbreak (lack of drug effect). Less than 2 years after receiving vaccination, the patient had worsening of her seizures and that her speech was getting worse. The patient provided very limited information and refused to provide demographics or answer questions related to adverse event.   No further information or details were provided by the caller. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation were unknown at the time of reporting. The reporter did not consent to follow-up.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months 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 case was self reported by the patient for himself. The patient experienced a sore arm for a few days before it resolved.  The reporter did not consent to follow-up. For tolerance to the 2nd dose, refer linked case US2022AMR002946.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR002946:Same reporter