chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: one week post vaccine dose 1, i have swelling and rash with hives on my left arm at injection site, it is itching terribly, applied Benadryl cream to help with itch. rash is spreading down my arm. and my arm feels very hot at injection site. i would also like to note that i have had extreme hyper episodes  post injection as well.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Psychomotor hyperactivity, Rash
Clinical narrative: one week post vaccine dose 1, i have swelling and rash with hives on my left arm at injection site, it is itching terribly, applied Benadryl cream to help with itch. rash is spreading down my arm. and my arm feels very hot at injection site. i would also like to note that i have had extreme hyper episodes  post injection as well.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dry skin, Palpitations, Skin discolouration, Skin warm
Clinical narrative: Reported heart racing was brought to lay down at 11:40 no further heart racing pulse 60, blood pressure 142/86. Client shaking.  No signs or symptoms of distress.  Respirations even and unlabored. Skin pink warm and dry.  Continuing to monitor.  1201 reported no further shaking and feeling that her chest  was heavy but stated i am ok. blood pressure 142/80 no signs of distress. 12:18 stated she is much better, no further signs or symptoms and no signs of distress. Informed to seek medical attention if further problems arise.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Reported heart racing was brought to lay down at 11:40 no further heart racing pulse 60, blood pressure 142/86. Client shaking.  No signs or symptoms of distress.  Respirations even and unlabored. Skin pink warm and dry.  Continuing to monitor.  1201 reported no further shaking and feeling that her chest  was heavy but stated i am ok. blood pressure 142/80 no signs of distress. 12:18 stated she is much better, no further signs or symptoms and no signs of distress. Informed to seek medical attention if further problems arise.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: one week post injection, injection site became red, swollen and itchy.  Rash last approx 24 hours.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: moderna covid 19 vaccine eua developed red rash around site  11 days after infection and a few red spots on face and torso
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Intraocular pressure test, Photopsia, Retinogram, Visual impairment, Vitreous floaters
Clinical narrative: 2 hours after receiving Pfizer COVID vaccine, vision in left eye presented with new floaters, flashes of light, and visual disturbance.  Described as constant by patient, has not resolved 3 days s/p vaccination
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for several hours, racing heart rate, sudden hot feeling, extreme headache, extreme fatigue, brain fog, irritability, pain at injection site.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Irritability, Palpitations, Paraesthesia
Clinical narrative: Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for several hours, racing heart rate, sudden hot feeling, extreme headache, extreme fatigue, brain fog, irritability, pain at injection site.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had a fever of 101.2 for 24 hours.  Difficulty getting fever down with  both Tylenol and Ibuprofen.  After 24 hours, fever was gone and no other symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Lymphadenopathy, Neck pain, Night sweats
Clinical narrative: Friday night - Sore arm and sore throat.  Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts.  And I'm still having night sweats plus am extremely hot but not having a fever.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Swelling
Clinical narrative: Friday night - Sore arm and sore throat.  Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts.  And I'm still having night sweats plus am extremely hot but not having a fever.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysphonia, Dyspnoea, Fatigue, Headache
Clinical narrative: Symptoms began about 45 mins after. Lower part of jawline was swollen. Not sure if it was the n95 mask. Throat got scratchy, sounding hoarse. Took Benadryl, extremely fast heart rate when moving around.  SOB walking to and from the bathroom. Extreme pain in back. Took Tylenol.  6am, Sat, woke up with headache and back was a tremendous pain. Took Tylenol every 6-8 hours. Today muscles in back are sore. No fever. Very fatigue today.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Oropharyngeal discomfort, Swelling face
Clinical narrative: Symptoms began about 45 mins after. Lower part of jawline was swollen. Not sure if it was the n95 mask. Throat got scratchy, sounding hoarse. Took Benadryl, extremely fast heart rate when moving around.  SOB walking to and from the bathroom. Extreme pain in back. Took Tylenol.  6am, Sat, woke up with headache and back was a tremendous pain. Took Tylenol every 6-8 hours. Today muscles in back are sore. No fever. Very fatigue today.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Injection site erythema, Injection site pruritus
Clinical narrative: Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on 2nd day with chills and tingly/prickly feeling all over, weakness/dizziness
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Injection site warmth, Paraesthesia, Pyrexia
Clinical narrative: Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on 2nd day with chills and tingly/prickly feeling all over, weakness/dizziness
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Volunteer received Moderna dose on 12/30 and then came in to receive 2nd dose on 1/6.  Received Pfizer dose on the 6th. She states feels fine, no adverse side effects. Instructed NOT to come on 1/27, when her next appointment was scheduled.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia oral
Clinical narrative: Numbing of tongue, possibly  mild Bell's Palsy, and occurred about 7 minutes after vaccination
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the evening - Aleve worked temporarily and then the side effects got worse, took another Aleve and eventually was able to sleep it off Arm aches at site of injection - still tender t otouch
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Pain, Pelvic pain
Clinical narrative: High fever that lasted until yesterday up to 101.9 F Severe headache Chills Body ache Abdominal pelvic pain  Patient reports having first dose of shingles vaccine 11/6/2020
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever that lasted until yesterday up to 101.9 F Severe headache Chills Body ache Abdominal pelvic pain  Patient reports having first dose of shingles vaccine 11/6/2020
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: tightening of chest, shortness of breathe, numbness/tingling in fingers and lips
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tightening of chest, shortness of breathe, numbness/tingling in fingers and lips
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Leg Rash Red rash and hot to touch on the injection site swollen around the injection site
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Swollen tongue
Clinical narrative: lient's tongue became swollen within 20 min. of vaccination.  Swelling did not resolve by 4:00pm, client seen at urgent care.  Client treated with Prednisone 60 mg PO x1; client prescribed Benadryl Q 4-6 hrs. x2 days, Prednisone 20 mg PO BID x5 days.  Client developed generalized pruritis and lip tingling approximately 12 hrs. post-vaccination.  Tongue swelling improved but not fully resolved at this writing  (72 hrs. post-vaccination).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Flushing, Gait disturbance, Impaired work ability
Clinical narrative: 52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions.  Provider will follow up in a few days to check on the patient.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Pyrexia, Rash erythematous, Swelling face
Clinical narrative: 52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions.  Provider will follow up in a few days to check on the patient.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 8:10 p c/o numbness, tingling, no sob, no dizziness, 120/76, 92 98% given H2O, rechecked 8:25p no changes in symp or V/S. Stayed on site for 40 mins symptoms resolved.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Chills, sweats, low grade fever, muscle aches, headache, fatigue, nausea. Symptoms started approximately 13 hours after vaccination and all resolved after almost 68 hours except for the muscle aches and fatigue.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, sweats, low grade fever, muscle aches, headache, fatigue, nausea. Symptoms started approximately 13 hours after vaccination and all resolved after almost 68 hours except for the muscle aches and fatigue.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Disorientation, Feeling abnormal, Impaired work ability, Malaise
Clinical narrative: Thursday evening  8:00 PM  6 Hour migraine 10/10 pain Friday: General feeling unwell Saturday 6:00 PM  sudden severe onset Nausea/ Diarrhea for 3 hours Sunday : General feeling of unease/disoriented Monday: No symptoms  Missed work Saturday and Sunday
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, SARS-CoV-2 test negative
Clinical narrative: Thursday evening  8:00 PM  6 Hour migraine 10/10 pain Friday: General feeling unwell Saturday 6:00 PM  sudden severe onset Nausea/ Diarrhea for 3 hours Sunday : General feeling of unease/disoriented Monday: No symptoms  Missed work Saturday and Sunday
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: C/O body aches, fatigue afternoon after vaccine. Following night had Fever 100.5, body aches. Fever decreased with tylenol.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Begining approx. 1/8/21, 11 days after the vaccine injection, the injection site is randomly very itchy and has a large red circle/ ring surrounding it. The red ring around the injection site is very large in size, about 3- 4 inches long and wide across my arm.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea
Clinical narrative: client was awaken early morning 2 days after covid vaccine with severe abdominal cramps and nausea. Called PCP and got prescription for meclizine that afternoon and that helped alleviate symptoms along with taking zofran, which client already had at home.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hair disorder, Headache, Hyperaesthesia, Lethargy
Clinical narrative: Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching and subsequent rash in the upper left arm around the inoculation site.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Eye pain, Injection site pain, Night sweats
Clinical narrative: Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain of skin, Pyrexia
Clinical narrative: Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Renal pain
Clinical narrative: Headache, nausea, right Kidney pain
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Migraine
Clinical narrative: Migraine and redness on the injection site
Age: 1.17
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: no adverse event; a 14 month old old was given PROQUAD and VARlVAX together yesterday on 12/28/20; This spontaneous was received from a medical assistant, concerning a 14 month old patient of unknown gender. No information was reported regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies.  On 28-DEC-2020 (reported as yesterday), the patient was given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) together for prophylaxis (strength, dose, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported) (duplicate therapy error). No further adverse event was reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Temperature excursion for VARlVAX; This spontaneous report has been received from a physician referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 11-DEC-2020, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) experienced a temperature excursion (product storage error). It was reported that on the same date, following the temperature excursion, the dose of the vaccine (also reported as: "the doses") was administered to the patient at a dose of 0.5 milliliter (mL) (formulation, route of administration, anatomical location and vaccination scheme were not provided; lot number T010315 has been verified to be a valid lot number, expiration date was reported and validated as 24-MAR-2022), as prophylaxis.  The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was a maximum temperature of 16.2 Fahrenheit degrees (F), for a time frame of 1 hour and 14 minutes, there was no previous temperature excursion. Additionally, a digital data logger was involved. No additional adverse events (AE) were reported.
Sex: U
Vaccine: TYP
Symptoms: Headache, Oral herpes
Clinical narrative: Labial herpes; Ocular headache; A spontaneous report was received from consumer on 16NOV2020.  The consumer (unknown gender and age) experienced labial herpes (PT: Oral herpes) and ocular headache (PT: Headache) while being on therapy with Vivotif for immunisation. The consumer asked "is it possible that in the days following taking the three doses I experienced a labial herpes and an ocular headache?". Action taken with Vivotif with respect to the reported events was unknown. The outcome of reported events was unknown.  Company Comment: A consumer had oral herpes and headache after a few days of taking three doses of Vivotif. Information on medical history, and further details of the event is limited. Oral herpes is a viral infection caused by herpes simplex virus, and the causality of oral herpes is assessed as not related to Vivotif. Considering the potential of Vivotif to cause headache, the causality of headache is assessed as possible.; Sender's Comments: A consumer had oral herpes and headache after a few days of taking three doses of Vivotif. Information on medical history, and further details of the event is limited. Oral herpes is a viral infection caused by herpes simplex virus, and the causality of oral herpes is assessed as not related to Vivotif. Considering the potential of Vivotif to cause headache, the causality of headache is assessed as possible.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Chest pain, Chills, Fatigue
Clinical narrative: skin sensitivity / sensitive skin that felt like a large sunburn; skin sensitivity with pain on his scalp; Pain on his chest; Pain in his abdomen; Shakiness of his hands; Arthralgias in his fingers; Sore throat; Chills; MUscle aches; Fatigue; Headache; This case was reported by a nurse via sales rep and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included varicella vaccine (dose received in 2010).   On 2nd November 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced headache. On 3rd November 2020, the patient experienced sore throat, chills, muscle pain and fatigue. On 12th November 2020, the patient experienced sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand. Shingrix was discontinued. On 4th November 2020, the outcome of the fatigue was recovered/resolved. In November 2020, the outcome of the headache was recovered/resolved. On 23rd November 2020, the outcome of the sore throat, chills, muscle pain, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand were recovered/resolved.   The reporter considered the headache, sore throat, chills, muscle pain, fatigue, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received first dose of Shingrix from his pharmacy. After receiving Shingrix, he had a headache that resolved. The following day, he had a sore throat, chills, muscle aches and fatigue. The next day he felt well. However, on 10th November 2020 he developed a sore throat, chills, and muscle aches. He had a COVID test that was negative, collected 11th November 2020. On 12th November 2020, 10 days later the patient had skin sensitivity with pain on his scalp, chest and abdomen, but no rash. He also had myalgias, shakiness of his hands and arthralgias in his fingers. He did not have a fever. The patient's myalgias improved, but he continued to have painful, sensitive skin that felt like a large sunburn. The patient's symptoms resolved 23rd November 2020. The reporter had decided already not to give the patient second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020255814:Duplicate case
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Gaze palsy, Headache, Hyperaesthesia, Myalgia, Oropharyngeal pain
Clinical narrative: skin sensitivity / sensitive skin that felt like a large sunburn; skin sensitivity with pain on his scalp; Pain on his chest; Pain in his abdomen; Shakiness of his hands; Arthralgias in his fingers; Sore throat; Chills; MUscle aches; Fatigue; Headache; This case was reported by a nurse via sales rep and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included varicella vaccine (dose received in 2010).   On 2nd November 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced headache. On 3rd November 2020, the patient experienced sore throat, chills, muscle pain and fatigue. On 12th November 2020, the patient experienced sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand. Shingrix was discontinued. On 4th November 2020, the outcome of the fatigue was recovered/resolved. In November 2020, the outcome of the headache was recovered/resolved. On 23rd November 2020, the outcome of the sore throat, chills, muscle pain, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand were recovered/resolved.   The reporter considered the headache, sore throat, chills, muscle pain, fatigue, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received first dose of Shingrix from his pharmacy. After receiving Shingrix, he had a headache that resolved. The following day, he had a sore throat, chills, muscle aches and fatigue. The next day he felt well. However, on 10th November 2020 he developed a sore throat, chills, and muscle aches. He had a COVID test that was negative, collected 11th November 2020. On 12th November 2020, 10 days later the patient had skin sensitivity with pain on his scalp, chest and abdomen, but no rash. He also had myalgias, shakiness of his hands and arthralgias in his fingers. He did not have a fever. The patient's myalgias improved, but he continued to have painful, sensitive skin that felt like a large sunburn. The patient's symptoms resolved 23rd November 2020. The reporter had decided already not to give the patient second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020255814:Duplicate case
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative, Tremor
Clinical narrative: skin sensitivity / sensitive skin that felt like a large sunburn; skin sensitivity with pain on his scalp; Pain on his chest; Pain in his abdomen; Shakiness of his hands; Arthralgias in his fingers; Sore throat; Chills; MUscle aches; Fatigue; Headache; This case was reported by a nurse via sales rep and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included varicella vaccine (dose received in 2010).   On 2nd November 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced headache. On 3rd November 2020, the patient experienced sore throat, chills, muscle pain and fatigue. On 12th November 2020, the patient experienced sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand. Shingrix was discontinued. On 4th November 2020, the outcome of the fatigue was recovered/resolved. In November 2020, the outcome of the headache was recovered/resolved. On 23rd November 2020, the outcome of the sore throat, chills, muscle pain, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand were recovered/resolved.   The reporter considered the headache, sore throat, chills, muscle pain, fatigue, sensitive skin, scalp pain, chest pain, abdominal pain, tremor of hands and pain in joint involving hand to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received first dose of Shingrix from his pharmacy. After receiving Shingrix, he had a headache that resolved. The following day, he had a sore throat, chills, muscle aches and fatigue. The next day he felt well. However, on 10th November 2020 he developed a sore throat, chills, and muscle aches. He had a COVID test that was negative, collected 11th November 2020. On 12th November 2020, 10 days later the patient had skin sensitivity with pain on his scalp, chest and abdomen, but no rash. He also had myalgias, shakiness of his hands and arthralgias in his fingers. He did not have a fever. The patient's myalgias improved, but he continued to have painful, sensitive skin that felt like a large sunburn. The patient's symptoms resolved 23rd November 2020. The reporter had decided already not to give the patient second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020255814:Duplicate case
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Flushing, Malaise
Clinical narrative: She was not feeling well and was very flush, weak, lightheaded; She was not feeling well and was very flush, weak, lightheaded; She was not feeling well and was very flush, weak, lightheaded; She was not feeling well and was very flush, weak, lightheaded; Felt the vaccine running through her body; This spontaneous case was received on 16-Dec-2020 with additional information received on the same day (being processed together) from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05804) and concerned an adult, female patient. At the time of this report, the patient was 63-year-old.  The patient's medical history and concomitant medications were not reported. The patient was receiving the flu vaccine for 10 years and never had a problem.   On 29-Oct-2018, the patient vaccinated with Afluria (TIV) (influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 333332418107 and expiry date was 22-Jun-2019.  On the same day, within two minutes after receiving Afluria (TIV), the patient was not feeling well and was very flush, weak, lightheaded and felt the vaccine running through her body. She went to the emergency room but began to feel better. There, she sat in the waiting room about a half hour and all symptoms resolved.   On the same day, the patient recovered from the events.   The reporter did not provide a causality assessment.  Company comment: The patient developed all events on the same day after receiving the suspect product, Afluria (TIV). Chronology is suggestive.The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events on the same day after receiving the suspect product, Afluria (TIV). Chronology is suggestive.The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Sex: U
Vaccine: FLUC3
Symptoms: Unevaluable event
Clinical narrative: Local reactions back to back; This spontaneous case was received on 17-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05827) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847, expiration date: 30-Jun-2021.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed local reactions back to back. It was not reported whether the patient received any corrective treatment.    The outcome of the event was unknown.  The reporter did not provide causality assessment.  The case is linked to the cases 202007727, 202007728 and 202007730 (the same reporter).  Company comment:The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash pustular
Clinical narrative: Fever, pussing rash all over front and back of legs,  arms, hands, and feet, a few on the face
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Eye swelling, Headache, Pain, Pollakiuria, Pyrexia
Clinical narrative: fever, headache, swollen face and eyes, body aches, excessive urination
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Swelling face
Clinical narrative: fever, headache, swollen face and eyes, body aches, excessive urination
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Rash pruritic, Urticaria
Clinical narrative: Eight days post vaccine I developed an itchy, hive like rash over the injection site.  It was approximately the size of a baseball in diameter.  Over the next two days the itching and hives disappeared but the redness expanded in size.  By the third day all symptoms were gone.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypertension, Hypoaesthesia oral, Pharyngeal swelling, Tongue pruritus
Clinical narrative: ? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pharyngeal swelling, Rash
Clinical narrative: Rash entire body,  throat swelling, extreme nausea.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to injection site
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in Left arm 3 hours after injection.  Evaluated in ER same day,  no deficits noted. Significant improvement within 24 hours of symptom onset, complete recovery within 48 hours of symptom onset.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Flushing, Heart rate increased
Clinical narrative: After vaccine became flushed across face and chest with racing pulse. Vitals taken, A&O x4; Answered questions appropriately. Pulse palpable and regular and fast. Given graham crackers and bottled water. Vital signs retaken along with blood glucose.  VS- 114/101 HR 94 138/93  HR 91 Glucose 91 Declined offered escort to ED. A&O x4; speech clear, resp evan. No signs of surface reaction at left arm site. Suggested follow up with PCP. Explained VAERS to patient.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles breakout about a week after 1st vaccine. Dermatology confirmed; medication given and treatment plan started.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Nausea
Clinical narrative: I received the vaccine in the late afternoon. I immediately Felt off. I was up most of the night with nausea and when I woke in the morning I was having both dizziness and Nausea. The nausea has subsided but I am still experience waves of dizziness.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Lip swelling, Swollen tongue
Clinical narrative: ACCORDING TO PATIENT STARTED WITH FEVER AFTER VACCINE THAT EVENING . THEN THE NEXT DAY SHE STARTED WITH SWELLING OF THE LIPS, TONGUE AND GUMS SO WENT TO ER WHERE SHE WAS GIVEN BENADRYL, TYLENOL AND STEROIDS
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Vaccine administration at 1230; Tightening/itching of throat @ 1242; Benadryl 25mg/10mL administered at 1242; symptoms resolved shortly after
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Dizziness, Headache
Clinical narrative: 1 hour after vaccine developed HA, 6 hours after vaccine Chills, fever, nausea, dry heaves, weakness, dizziness, chest tightness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Retching
Clinical narrative: 1 hour after vaccine developed HA, 6 hours after vaccine Chills, fever, nausea, dry heaves, weakness, dizziness, chest tightness
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea, Palpitations
Clinical narrative: Pt felt a hot flush and heart racing about 5 mins after vaccination.  BP 122/64, P 88-104, 96-99% O2 on RA.  Denied SOB, throat tightening, cough, swelling of lips, tongue or face.  Pt did become nauseous and had 2nd hot flush with HR going to 104.  Pt transported to ED for evaluation.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: COVID vaccine administration error.  Pfizer mRNA COVID vaccine dose #2 given at wrong interval.   Dose #1 received December 27th, 2020 Dose #2 received January 10th, 2021  Patient apprised of error.  Patient verbalizes understanding that dose will need to be repeated.   Patient was observed for 15 minutes per protocol; no complication noted.   Patient was discharged from clinic.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Approximately 6 minutes after receiving vaccine, pt laid in supine position with knees bent. RN went to check on patient who reported headache with "mild dizziness." Patient was A and O x3 and denied difficulty breathing or SOB. HR 74, SpO2 99, and RR 17.Patient reports she had a smoothie this AM. Encouraged patient to remove mask, take deep breaths, and slow sips of water. Had patient remain in supine position for 10 minutes. VS reevaluated at 1236-SPO2 97, HR 69, BP 128/75, and RR 15. Patient reports improvement in symptoms. Encouraged pt to rest for 15 more minutes. Patient reports she "is feeling better"-HR 73-SPo2 99. No difficulty ambulating-escorted to car by staff RN. Referred to PCP.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills, severe body aches - Tylenol taken at 7:40 PM which resolved most of the symptoms. No fever.  Body aches the next day but manageable without medication. All symptoms resolved after 48 hours.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: large red swollen around injection site
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Loss of consciousness
Clinical narrative: During the middle of the night, fever, headache, chest pressure/shortness of breath.  By early morning the following day, severe dizziness and fainting.  Felt like orthostatic hypotension.  Could not even sit up in bed without blacking out.  Lasted for hours until about midday
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Orthostatic hypotension, Pyrexia, Syncope
Clinical narrative: During the middle of the night, fever, headache, chest pressure/shortness of breath.  By early morning the following day, severe dizziness and fainting.  Felt like orthostatic hypotension.  Could not even sit up in bed without blacking out.  Lasted for hours until about midday
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Chills, Muscle Ache, Joint Ache, Head Ache
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Fall, Head injury, Syncope
Clinical narrative: syncopal episode 16 hours post vaccination with fall to floor and struck head.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Resident died suddenly and expectantly on 01/05/2021
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Flushing, Pain in extremity, Pyrexia, Rash
Clinical narrative: Patient had Moderna vaccination on 12/30/2020 at 1010.  Approximately 4 hours after injection reaction were flush face, slight fever, tachycardia (base line 50 reaction rate 97), skin rash on both forearms.  Symptoms lasted about 1 hour. Approximately 4 hours later symptoms of flush face, and fatigue returned. Fatigue and arm pain of 4/10 lasted through 12/31. 1/1/2021 only arm pain remained at 2/10 and lasted an additional 2 days.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Tachycardia
Clinical narrative: Patient had Moderna vaccination on 12/30/2020 at 1010.  Approximately 4 hours after injection reaction were flush face, slight fever, tachycardia (base line 50 reaction rate 97), skin rash on both forearms.  Symptoms lasted about 1 hour. Approximately 4 hours later symptoms of flush face, and fatigue returned. Fatigue and arm pain of 4/10 lasted through 12/31. 1/1/2021 only arm pain remained at 2/10 and lasted an additional 2 days.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Impaired work ability, Pain, Pyrexia
Clinical narrative: I started with low-grade fever and chills about 12h after receiving my second dose of the Pfizer covid19 vaccine. Chills lasted for about 15min, they were of moderate intensity. Then I had low grade fever, body ache and tiredness for the entire next day (01/08/2021); it was bad enough to interfere with my regular activities of work and childcare. I ended up taking the day off. On the following day (01/09/2021), I woke up fully restored.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 9:10 p c/o of dizziness and lightheaded, 122/78, 97, 100% given H2O, rechecked at 9:25p V/S unchanged and dizziness and lightheadedness subsided. remained on site 30 mins. no symptoms, told to follow up with PCP or 911 if symptoms return
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Lymph node pain, Lymphadenopathy
Clinical narrative: About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down the bottom of my arm to my elbow on my right side. This is the same side the injection was given. The injection site is no longer tender to touch but it is difficult to raise my arm and hold it straight due to discomfort. My arm is visibly swollen compared to my left arm. I can feel shotty lymph nodes down my arm.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dissociation, Dizziness, Dizziness postural, Heart rate decreased
Clinical narrative: Patient said right after the shot that her head felt was not attached to her body. This occurred at 10:35am. She got very dizzy. Her bp was 192/88 and HR 57. We continued to monitor her BP/HR.   Her bp remained elevated for over 40 minutes. Her rate rate did dip to 43 at one time. The patient tried sitting up 3 times but became extremely dizzy and quickly laid back down.  At 11:10am, she was finally able to leave.  The patient reported that she didn't eat breakfast this am. We gave her crackers and orange juice. This seemed to really help. She also has a history of hypertension , and she forgot to take her medication this am. Her daughter was going to take her right home to  take her medicine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Diarrhoea, Impaired work ability, Muscular weakness
Clinical narrative: Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test negative
Clinical narrative: Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic, Scab
Clinical narrative: 2 DAYS AFTER VACCINE PATIENT NOTICED A SMALL BUMP ON HIS SIDE. THIS HAS TURNED INTO BUMPS ALL OVER HIS BODY. THE PT REPORTS THAT THE BUMPS ARE ITCHY AND HAVE SOME FLUID. HE REPORTS THAT THE FLUID BUMPS LAST A COUPLE OF DAYS AND THEN SCAB OVER. THE PT HAS HAD CHICKEN POX AND HAS BEEN VACCINATED.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Ultrasound kidney, Urine analysis
Clinical narrative: Chills , low grade fever ,   Possible Kidney infection
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Arms warm and red for approximately 10 minutes
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Pruritus
Clinical narrative: excruciation pain swollen, red shoulder that is itchy red itchy band around arm really itchy redness comes and goes red circle that itches is right below the injection middle of upper arm is itchy
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Decreased appetite, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever of 101.0F Malaise Fatigue Generalized myalgias and arthralgias Loss of appetite
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Pain in extremity, Skin warm
Clinical narrative: Upper arm became, bright red,  hot to touch, slightly sore,  water blister
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Hypoaesthesia, Paraesthesia
Clinical narrative: Client became weak, diaphoretic, numb/tingling limbs, almost lost conciousness
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Erythema, Neck pain, Oedema
Clinical narrative: fever, erythema, edema, pain radiating distally to hand and chest, back, and neck
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: fever, erythema, edema, pain radiating distally to hand and chest, back, and neck
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache, fatigue
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Syncope, Vomiting
Clinical narrative: Woke up during the night and experienced vomiting and diarrhea followed by syncope
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling cold, Headache, Hypersomnia
Clinical narrative: I had a slight headache while at work but was fine. I was home and was a little cold and my throat was scratchy. . Then about 9pm all of a sudden I started to get waves of chills. My hand were cold and my feet were frozen. I layered up with sweater and sweatpants to go to bed with a heavy comforter. I just could not get warm. About 1am, I woke up and put on my thick winter socks on because my feet were still frozen. I kept reminding myself to breathe in deeply.  I checked my BPM and it was 80-82 and normally its about low  70s. I woke up about 5:30am and had a really bad headache, injection area and arm hurt, my  body hurt and felt like I weighed several tons making me so slow. I didn't go to work the next day. My husband took my son to school and I took ibuprofen and went back to bed. Woke up again about 12:30 and felt better.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site pain, Pain, Peripheral coldness, Sleep disorder
Clinical narrative: I had a slight headache while at work but was fine. I was home and was a little cold and my throat was scratchy. . Then about 9pm all of a sudden I started to get waves of chills. My hand were cold and my feet were frozen. I layered up with sweater and sweatpants to go to bed with a heavy comforter. I just could not get warm. About 1am, I woke up and put on my thick winter socks on because my feet were still frozen. I kept reminding myself to breathe in deeply.  I checked my BPM and it was 80-82 and normally its about low  70s. I woke up about 5:30am and had a really bad headache, injection area and arm hurt, my  body hurt and felt like I weighed several tons making me so slow. I didn't go to work the next day. My husband took my son to school and I took ibuprofen and went back to bed. Woke up again about 12:30 and felt better.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: I had a slight headache while at work but was fine. I was home and was a little cold and my throat was scratchy. . Then about 9pm all of a sudden I started to get waves of chills. My hand were cold and my feet were frozen. I layered up with sweater and sweatpants to go to bed with a heavy comforter. I just could not get warm. About 1am, I woke up and put on my thick winter socks on because my feet were still frozen. I kept reminding myself to breathe in deeply.  I checked my BPM and it was 80-82 and normally its about low  70s. I woke up about 5:30am and had a really bad headache, injection area and arm hurt, my  body hurt and felt like I weighed several tons making me so slow. I didn't go to work the next day. My husband took my son to school and I took ibuprofen and went back to bed. Woke up again about 12:30 and felt better.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Multiple swollen and tender lymph nodes on left side of neck and collar bone found week after injection.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 6 days after shot, my arm is swollen, sore and has a fever. Redness is spreading.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 6 days after shot, my arm is swollen, sore and has a fever. Redness is spreading.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain
Clinical narrative: Extreme body aches, chills, joint pain, fatigue.  800mg ibuprofen taken which somewhat relieved symptoms, but not completely.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 100.0 temporal with no further symptoms