chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: at 8:40 am patient felt dizzy and flushed, she asked for extra attention and indicated she felt embarrassed, but denied difficulty breathing, no trouble speaking in full sentences, no rash, no change of vision;  BP was 158/108 with pulse of 95 and then patient was brought to a more quiet area and seated in a wheelchair.   She was able to ambulate, a nd speak normally, but she said she felt very strange and shaky.  she was visibly tremulous.  She was seated, and vitals reassessed and her shakiness increased and she felt panicky.  She was taken by stretcher to the Emergency room for further observation .   in the emergency room, her symptoms gradually subsided.  She was able to return to work after an hour of observation.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Palpitations
Clinical narrative: Palpitations with HR of 120 within 5 minutes after receiving the vaccine. Wheeled to the ER for further evaluation. Dizziness and high BP.  Was given Benadryl, Pepcid and Solu-Medrol and a liter of NS. Discharged after 2 hours with Benadryl and Prednisone prescribed for home meds.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash macular
Clinical narrative: Moderna COVID-19 Vaccine  Developed some blotchy bruising on the bottom half of both legs within 12 hours of receiving the vaccine
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: About 6 hours after injection, injection site pain worsened. This continued to worsen until about 48H post-injection. About 30 hours from injection, experienced aches and feverish feeling without elevated temperature. Aches primarily in joints of hands, feet, knees, back pain, neck stiffness.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Paraesthesia, Vomiting
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine  Dizziness, headache, generalized tingling.  No reactions to vaccines in the past.  Rapid response called, BP 187/104, O2 sat 100% on Room Air. nauseous, vomited 2-3 times. admitted to ER, discharged 3 hrs later, BP normal 122/73
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Started with sore arm and progressed to fever up to 103.0, chills, vomiting, body and joint aches.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Started with sore arm and progressed to fever up to 103.0, chills, vomiting, body and joint aches.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelids pruritus, Pruritus
Clinical narrative: Eyelids are itchy, neck itchy.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Injection site pain, Pneumonia, Pyrexia, Rales
Clinical narrative: I had a fair amount of pain at the injection site, by night time I had crackling in my lungs and weezing and a low grade temparture.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Wheezing
Clinical narrative: I had a fair amount of pain at the injection site, by night time I had crackling in my lungs and weezing and a low grade temparture.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Injection site pain, Pain
Clinical narrative: Injection site sensitivity, unable to have anything on my arm without significant pain. Movement of any kind of my left arm, even wiggling a finger, cause significant pain radiating throughout my entire left arm
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Received the vaccine on 12/18 and 1820. She developed lip swelling for 24 hours. Took Benadryl and the swelling resolved after 24 hours. No other side effects.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  metallic taste
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: - Received Vaccine 1045 AM 12/19 - Sore arm at injection site started later that day and persisted - On morning of 12/21 I had a mild headache, and by mid day had some muscle aches - Night of 12/21 could not get rid of fever, sweats, chills, muscle aches, headache - Symptoms persisted, and decided this may be something else as well - Tested positive for covid on 12/23 (got results today 12/24)
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: - Received Vaccine 1045 AM 12/19 - Sore arm at injection site started later that day and persisted - On morning of 12/21 I had a mild headache, and by mid day had some muscle aches - Night of 12/21 could not get rid of fever, sweats, chills, muscle aches, headache - Symptoms persisted, and decided this may be something else as well - Tested positive for covid on 12/23 (got results today 12/24)
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: At 8:55am individual reported a tingling sensation down the right side of face radiating down to upper deltoid/arm area.  Individual described the sensation as a feeling of pins & needles.  At 9:10 individual reported the symptom was gone.  At 9:12am Blood Pressure 120/76, Pulse 90 and Respirations 20.  Blood Pressure and Pulse taken using an automatic machine using the left arm.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Pfizer-BioNTech COVID-19 EUA  metallic taste in back of mouth
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Injection site bruising, Injection site swelling
Clinical narrative: On 12/22:First noticed roof of mouth started to itch, back of throat itching, difficult to swallow, noticed hives on chest/torso, difficult breathing, wanted to vomit, close to fainting.  Hives around injection site.  Placed on gurney and sent to ER.  In ER given epi-pen injection, benadryl injection, albuterol, pepcid, toradol, solu-medrol and observed for 4 to 5 hours.  On 12/23: Hives still present, injection site has two large bruises on arm; arm in swollen down to elbow.  Broke out in hives on chest and face.  Re-evaluated in ER.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Nausea, Oral pruritus, Throat irritation, Urticaria
Clinical narrative: On 12/22:First noticed roof of mouth started to itch, back of throat itching, difficult to swallow, noticed hives on chest/torso, difficult breathing, wanted to vomit, close to fainting.  Hives around injection site.  Placed on gurney and sent to ER.  In ER given epi-pen injection, benadryl injection, albuterol, pepcid, toradol, solu-medrol and observed for 4 to 5 hours.  On 12/23: Hives still present, injection site has two large bruises on arm; arm in swollen down to elbow.  Broke out in hives on chest and face.  Re-evaluated in ER.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Dysgeusia, Lethargy
Clinical narrative: Metallic taste in mouth, lethargy
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash, Rash pruritic, Skin exfoliation
Clinical narrative: EE c/o pruritic rash on trunk and peeling of skin on hands
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Swelling face
Clinical narrative: Patient developed face and periorbital swelling 3 days after receiving covid vaccine. Swelling continued next day, responding to antihistamine treatment
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia oral, Muscle tightness, Paraesthesia oral, Throat tightness
Clinical narrative: 30 min after dose felt like my tongue was getting thicker, neck and throat felt tight, tingling around upper gum line near front teeth. Slight numbness in skin around upper mouth.  Difficulty swallowing for five hrs post dose and I took 50mg of Benadryl at 730pm when I got to my car. Swelling in throat and back of mouth remained same from 530-730, gradually noticed improvement at 1015 pm
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue disorder
Clinical narrative: 30 min after dose felt like my tongue was getting thicker, neck and throat felt tight, tingling around upper gum line near front teeth. Slight numbness in skin around upper mouth.  Difficulty swallowing for five hrs post dose and I took 50mg of Benadryl at 730pm when I got to my car. Swelling in throat and back of mouth remained same from 530-730, gradually noticed improvement at 1015 pm
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Enlarged uvula, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: 30 min after dose felt like my tongue was getting thicker, neck and throat felt tight, tingling around upper gum line near front teeth. Slight numbness in skin around upper mouth.  Difficulty swallowing for five hrs post dose and I took 50mg of Benadryl at 730pm when I got to my car. Swelling in throat and back of mouth remained same from 530-730, gradually noticed improvement at 1015 pm
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: 30 min after dose felt like my tongue was getting thicker, neck and throat felt tight, tingling around upper gum line near front teeth. Slight numbness in skin around upper mouth.  Difficulty swallowing for five hrs post dose and I took 50mg of Benadryl at 730pm when I got to my car. Swelling in throat and back of mouth remained same from 530-730, gradually noticed improvement at 1015 pm
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dry mouth, Fatigue, Headache
Clinical narrative: Within an hour and half I started to experience Dry Mouth and Nausea, later that day my Lymph  nodes in my neck/jaw were Swollen and I had a Runny nose and Cough. By the evening I was experiencing Body Aches, Chills, Headache, and Fatigue.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Rhinorrhoea
Clinical narrative: Within an hour and half I started to experience Dry Mouth and Nausea, later that day my Lymph  nodes in my neck/jaw were Swollen and I had a Runny nose and Cough. By the evening I was experiencing Body Aches, Chills, Headache, and Fatigue.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Gait disturbance, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: REQUESTED BY THIS WRITER PRIOR TO INJECTION FOR HEALTH TO RECORD PROCEDURE ON PERSONAL CELLPHONE. INJECTION GIVEN TO RIGHT DELTOID. LESS THAN 1 HOUR APPROXIMATELY 3:50PM TINGLING, PINCHING FEELING TO RIGHT HAND BEGAN THEN NUMBNESS STARTED TO RIGHT ARM FOLLOWED BY SAME SENSATION ON RIGHT LOWER EXTREMITY. MEDICINE CUP STARTED TO FEEL HEAVY AND I WASNT ABLE TO WALK CORRECTLY (LIMPING).  HEALTH VERBALIZED "TO CONTINUE MONITORING YOURSELF WHILE WORKING". APPROXIMATELY 4:35PM NUMBNESS IS FELT TO RIGHT SIDE OF FACE, FACIAL DROOPING VISUALLY SEEN ON RIGHT SIDE OF FACE. ADVISED HEALTH TO GO TO ER. HEALTH DROVE THIS WRITER TO THE ER
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site mass, Injection site swelling, Pain in extremity, Respiratory tract congestion
Clinical narrative: Swelling and hard lump around injection site, I noticed it about 24 hours after the injection  and it remains approx. 45 hours after the injection. The arm of the injection site has hurt since about an hour after the shot. I noticed some slight dizziness about 20 minutes after the shot but that was gone within about 10 minutes. I woke up with some congestion the morning after the shot.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site and radiating into shoulder, extreme fatigue and tiredness, headaches, dizziness and nausea. Overall feeling of maliase
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain
Clinical narrative: Pain and swelling at injection site and radiating into shoulder, extreme fatigue and tiredness, headaches, dizziness and nausea. Overall feeling of maliase
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Approximately 48 hours after receiving injection she began developing papular, erythematous rash to left arm spread throughout the day.  Following day same rash description occurred to right arm.  Papules clustered to left posterior leg, faint to anterior legs, anterior superior chest.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Diarrhoea haemorrhagic, Faeces discoloured
Clinical narrative: 12/22 7 pm, severe leg cramps; 12/23 7 am: diarrhea, abdominal pain. noon: nausea requiring medication; 5 pm, shaking chills, normal temperature. 9 pm: bloody diarrhea, and what looked more like sloughing nonpigmented tissue rather than stool, continued abdominal pain. Woke with diarrhea and pain 1 am. This morning, frequent stool and moderate abdominal pain.  No chills.   Recovered from diverticulitis around 12/3, scheduled for colonoscopy 1/6/21 and probably colectomy 1/8/2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements, Muscle spasms, Nausea, Pain, Tremor
Clinical narrative: 12/22 7 pm, severe leg cramps; 12/23 7 am: diarrhea, abdominal pain. noon: nausea requiring medication; 5 pm, shaking chills, normal temperature. 9 pm: bloody diarrhea, and what looked more like sloughing nonpigmented tissue rather than stool, continued abdominal pain. Woke with diarrhea and pain 1 am. This morning, frequent stool and moderate abdominal pain.  No chills.   Recovered from diverticulitis around 12/3, scheduled for colonoscopy 1/6/21 and probably colectomy 1/8/2021.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Chills, Myalgia
Clinical narrative: Chills,  weakness, muscle and joint pain
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product label issue
Clinical narrative: When I filled out visage I put the wrong brand of vaccine and need to change it.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain and slight swelling in left arm at injection site with pain upon movement and touching site, muscle aches all over body, severe pounding headache/migraine, fever up to 101° 12/24/2020 at 11:00 am, first fever at 100.3° at 3:14 am 12/24/2020, tachycardia at 164 bpm at 3:30 am 12/24/2020, tachycardia into high 120s with walking 12/24/2020 around 10 am 12/24/2020, chills, light sensitivity, weakness when fever spikes, and overall malaise.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Myalgia, Pain, Photophobia
Clinical narrative: Pain and slight swelling in left arm at injection site with pain upon movement and touching site, muscle aches all over body, severe pounding headache/migraine, fever up to 101° 12/24/2020 at 11:00 am, first fever at 100.3° at 3:14 am 12/24/2020, tachycardia at 164 bpm at 3:30 am 12/24/2020, tachycardia into high 120s with walking 12/24/2020 around 10 am 12/24/2020, chills, light sensitivity, weakness when fever spikes, and overall malaise.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Pain and slight swelling in left arm at injection site with pain upon movement and touching site, muscle aches all over body, severe pounding headache/migraine, fever up to 101° 12/24/2020 at 11:00 am, first fever at 100.3° at 3:14 am 12/24/2020, tachycardia at 164 bpm at 3:30 am 12/24/2020, tachycardia into high 120s with walking 12/24/2020 around 10 am 12/24/2020, chills, light sensitivity, weakness when fever spikes, and overall malaise.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on the torso
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injected limb mobility decreased, Malaise, Pain in extremity
Clinical narrative: On 12/22/20 I began to feel fatigued and sore arm at 1900.  By 2330 on 12/22/20 my left arm was hurting down to my fingertips and extremely painful.  I took 2 325 mg Tylenol and went to sleep.  I tried sleeping but felt like my heart was coming out of my chest.  I checked my Heartrate and it was between 100-120.  I could not sleep all night.  My left arm was so painful that I could not sleep on it or lift it above the level of my heart. On 12/23/20 I was very fatigued.  I went about my day but was not feeling well.  By 1900 on 12/23/20 I was running a low grade fever 99.9 and felt terrible.  I took 2 325mg Tylenol and 2 200mg ibuprofen to help with the pain.  I went to sleep and woke feeling better.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Sleep disorder
Clinical narrative: On 12/22/20 I began to feel fatigued and sore arm at 1900.  By 2330 on 12/22/20 my left arm was hurting down to my fingertips and extremely painful.  I took 2 325 mg Tylenol and went to sleep.  I tried sleeping but felt like my heart was coming out of my chest.  I checked my Heartrate and it was between 100-120.  I could not sleep all night.  My left arm was so painful that I could not sleep on it or lift it above the level of my heart. On 12/23/20 I was very fatigued.  I went about my day but was not feeling well.  By 1900 on 12/23/20 I was running a low grade fever 99.9 and felt terrible.  I took 2 325mg Tylenol and 2 200mg ibuprofen to help with the pain.  I went to sleep and woke feeling better.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, SARS-CoV-2 test negative
Clinical narrative: Physician called to report an adverse reaction to the COVID-19 vaccine.  Patient  had a 6.5 cm x 6.5 cm reaction at her injection site.   This included erythema, warmth, and swelling.    The patient also reported chills.    Patient's O2 saturation measured at 80% a few hours after the vaccination.   Patient received a liter of oxygen on Saturday and Sunday.    Patient was tested for COVID-19 and had a negative result.    On Monday and Tuesday, patient was given 25mg of oral diphenhydramine as the injection site had not improved.     Patient has a mild history of asthma, but is not currently taking any medications for that condition.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling, Pyrexia
Clinical narrative: ARM EXTREMELY SWOLLEN; SHE SPIKED A HIGH FEVER OVERNIGHT; LOT OF REDNESS AT INJECTION SITE  NO TREATMENT SOUGHT
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: I developed fever and chills and headach for 2 nights now  my fever was a 102.3 lasted at least 6-8 hours  had Pfizer-bioNTech COVID-19vaccine
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  reported headache that she did not have prior to injection
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Severe  total body muscle ache, fatigue,chills lasting about 40 hours after vaccine. Inabilty to lift left arm more than 45 degrees due to severity of arm pain. Improving
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Pruritus, Rash
Clinical narrative: bumps on wrists with loss of hair, itchiness
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  metallic taste, relieved after drinking water
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Facial paresis, Hypoaesthesia
Clinical narrative: Woke up with onset of left sided facial weakness, paralysis, and numbness around 0600. Was evaluated in the ER and diagnosed with Bell?s Palsy.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lip swelling, Oedema peripheral, Paraesthesia oral
Clinical narrative: initial fatigue, chills. After 24 hours, extreme fatigue, lips tingled, went to bed. In am, about40 hours after vaccination developed swollen upper lip and swollen armpit on side where she was vaccinated.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: Pt complains of stiff shoulder with reduced range of motion with discomfort. Pt has taken ibuprofen and used a heating pad with little improvement. Pt will see PCP within a month. (is aware of the condition, SIRVA, and is very deliberate when properly locating the area for vaccination - do not believe this is the cause of Pt's reaction). Pt is planning to follow-up with PCP.
Age: 67.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a female patient received the FLUZONE QUADRIVALENT at their office on 28Oct2020 and another dose of the flu vaccine yesterday with no AE; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a nurse via The Agency (Reference number- 00370464).  This case involves a 67 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] at their office on 28-Oct-2020 and another dose of the INFLUENZA VACCINE on 23-Nov-2020 [batch number and expiration date not reported] via an unknown route and site for prophylactic vaccination (extra dose administered).  The patient's medical history, medical treatments, vaccinations, family history and concomitant medication were not provided.  It was a case of an actual medication error due to extra dose administered (latency unknown).  Upon transfer, nurse was not aware of any adverse effects patient is experiencing at this point. Nurse stated that the patient received the second flu vaccine at an outside pharmacy, so she does not know that brand of flu vaccine it was, or whether it was a Sanofi product or not.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick with something; Initial information was received on 12-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case  was linked with 2020SA358166 (same reporter).  This case involves female patient (unknown age) who sick with something (Illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date in September 2019, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in November 2019, the patient experienced sick with something (Illness), (unknown latency) following the administration of influenza vaccine.  It was reported that, the reporter had question about if the flu shot works then why did they get sick or was it the new virus COVID19.  No laboratory data was provided.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sick; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who got sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: very sick; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who was very sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that, had not taken flu shot since, nor have had the flu since then.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: a 63 years old patient received a dose Fluzone Quadrivalent High Dose /No AE; a 63 years old patient received a 0.7 ml dose Fluzone Quadrivalent High Dose /No AE; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a Nurse Practitioner via Medical Information (Reference number- 00370456).  This case involved 63 years old female who received a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route in unknown administration site on 11-Nov-2020 for prophylactic vaccination (Product administered to patient of inappropriate age and Overdose).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  This case was of an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone Quadrivalent High Dose Medication Error as the patients being under the age of 65 at time of vaccination with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number- 00370469) and transmitted to Sanofi on 24-Nov-2020.  This case involves a 60 year old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 11-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number unknown strength standard) at a dose of 0.7 mL via an intramuscular route in an unknown administration site prophylactic vaccination as a medication error as the patient being under the age of 65 at time of vaccination (product administered to patient of inappropriate age and incorrect dose administered).  It was a actual medication error due to Inappropriate age at vaccine administration.   The Nurse Practitioner reported that a staff member administered the incorrect doses due to not paying attention to what was being given and to whom it was being given to and that there is limited information due to the caller not having the information.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information regarding the batch number for the case.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Pain
Clinical narrative: Headache started AM of 12/23/20; Body aches started 1100 12/23/20; lymph node discomfort, same arm as vaccine, early AM 12/24/20;  Alternating Tylenol, naproxyn and rest helps. Once meds wear off, symptoms return.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Pain, Pyrexia
Clinical narrative: body aches, fever 100.5 oral, cough, upset stomach
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Complaints of warm sensation on her throat @ 10:15 am. VS bp 165/77, Pulse 136, O2 sat 99%.  10:30 BP 133/96, Pulse 121 O2 sat 100%  Had sips of water and tolerated well 10:40 complaining of warm sensation to the left side of body. Send to ED for further evaluation accompanied by an RN
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Chest pain, Heart rate increased
Clinical narrative: About 1 hour after leaving the clinic, mom called and reported that Pt was having chest pain and feeling like her heart was beating faster than normal. No other symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Fever malaise headache tired slightly dizzy
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Lip swelling, Mouth swelling, Rash
Clinical narrative: 3-5 minutes following administration of vaccine patient experienced itching and swelling of upper lip, swelling of mouth, rash bilateral arms. Benadryl 50mg intramuscular was administered and additional 30 minutes of observation conducted. ER referral was offered to the patient, she declined.  B/P 135/82 and HR 85 at time of check out.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed after injection
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache,muscle ache,injection site pain, tiredness, chills,joint pain, feeling unwell.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Headache,muscle ache,injection site pain, tiredness, chills,joint pain, feeling unwell.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Pruritus
Clinical narrative: I start to have allergic rashes on random places on my body. I need to take benedryl to stop the itchiness for the past 2 days and ongoing. It appears off and on.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: Patient reported a headache and some itching.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Lightheadedness and palpitation
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Erythema, Flushing, Heart rate increased
Clinical narrative: Once I received the vaccine 2 secs immediately started feeling flushed , blood rush going up to face, heart beat more rapid, and exp difficulty breathing. I spoke with staff was taken for a observation area and  had a EKG. While being observed after 5 mins felt as if I couldn't breathe. Around the 5 of 10 mins mark started feeling better and at 10 mins felt totally fine.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction
Clinical narrative: Once I received the vaccine 2 secs immediately started feeling flushed , blood rush going up to face, heart beat more rapid, and exp difficulty breathing. I spoke with staff was taken for a observation area and  had a EKG. While being observed after 5 mins felt as if I couldn't breathe. Around the 5 of 10 mins mark started feeling better and at 10 mins felt totally fine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pain
Clinical narrative: side effect: temp 101:  moderated body aches for 24 hours.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache Fatigue
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Fatigue, Headache, Hypogeusia
Clinical narrative: I?m having sore muscles, joints pain, headache, reduced tasting, fatigue, nose congestion, sore throat, heavy chest, and facial swelling. It?s been like this since I got my shot.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain, Swelling face
Clinical narrative: I?m having sore muscles, joints pain, headache, reduced tasting, fatigue, nose congestion, sore throat, heavy chest, and facial swelling. It?s been like this since I got my shot.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: INCOMPLETE vaccination d/t faulty needle. Part of the vaccine dripped out of needle hub and was not administered to patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling cold, Hyperhidrosis, Injection site pain
Clinical narrative: Pfizer-BioNTech Covid 19 Vaccine: Patient reports "indescribable" muscle pain beginning almost exactly 4 hours after vaccination which has persisted until time of this report (day 7).   She notes minimal pain at injection site.  Has had no fever, no nausea/vomiting/diarrhea.  She states that her entire body hurts, including hair, teeth, toenails, and fingernails - she describes as throbbing pain.  She also reports pain in back and thoracic muscles to the extent that she cannot bend down to put on shoes.  She notes that the back pain was not initially present but started around day 5 (12/22/20).  She describes this as muscle pain and does not have visceral pain.   She reports some relief with acetaminophen and ibuprofen.  She also describes alternating episodes of feeling "freezing cold" with shaking chills followed by profuse diaphoresis (describes sweat as pooling and dripping).  Acetaminophen and ibuprofen have not relieved or lessened the episodes of chills and sweats.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: Pfizer-BioNTech Covid 19 Vaccine: Patient reports "indescribable" muscle pain beginning almost exactly 4 hours after vaccination which has persisted until time of this report (day 7).   She notes minimal pain at injection site.  Has had no fever, no nausea/vomiting/diarrhea.  She states that her entire body hurts, including hair, teeth, toenails, and fingernails - she describes as throbbing pain.  She also reports pain in back and thoracic muscles to the extent that she cannot bend down to put on shoes.  She notes that the back pain was not initially present but started around day 5 (12/22/20).  She describes this as muscle pain and does not have visceral pain.   She reports some relief with acetaminophen and ibuprofen.  She also describes alternating episodes of feeling "freezing cold" with shaking chills followed by profuse diaphoresis (describes sweat as pooling and dripping).  Acetaminophen and ibuprofen have not relieved or lessened the episodes of chills and sweats.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Immediate post-injection reaction, Throat irritation
Clinical narrative: Pt felt rush of warmth throughout body immediately after vaccine administered.  About  30 minutes later, he felt itchiness at the back of his throat.  Pt was accompanied to ER , where he received solumederol 125 mg, pepcid 20 mg and benadryl 50 mg IV.  Pt symptoms resolved post medication.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Malaise, Throat irritation
Clinical narrative: Pt felt rush of warmth throughout body immediately after vaccine administered.  About  30 minutes later, he felt itchiness at the back of his throat.  Pt was accompanied to ER , where he received solumederol 125 mg, pepcid 20 mg and benadryl 50 mg IV.  Pt symptoms resolved post medication.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Laboratory test normal, X-ray normal
Clinical narrative: The day following vaccination I had very, very painful joint pain throughout my body.  In particular my hips were so painful that walking was difficult.  I've never had a hip  injury or problems with hip pain.  My doctor  eventually ordered x-rays of both hips and blood work to rule out other possible causes.   All tests showed that I was perfectly healthy.  The pain in most of my joints has subsided considerably, but my hips continue (now over two months following the vaccination date) to be painful.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Thrombosis
Clinical narrative: Very mild, but unexpected nose bloody nose from left nostril. Only noted when blowing nose. With 1 clot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Mild Nausea, headache, body aches, fatigue
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Oropharyngeal pain, Rhinorrhoea, Throat irritation
Clinical narrative: Had sore throat, itchy throat, cough, running nose and shortness of breath started yesterday.  But shortness of breath has gone away this morning.  Anything she need to do?
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: Headache, Body aches, nausea
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Visual impairment
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  ~30 minutes post injection developed bilateral visual disturbance best described as an aura (shiny waves) in my inferior visual fields. No associated migraine/HA, photophobia, N/V, etc. This lasted for ~ 2 hours, did NOT hinder my day-to-day activities that day.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Extrasystoles, Fatigue, Heart rate increased, Hypoaesthesia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine  4 minutes after the injection, my heart felt like it skipped a beat and my heart rate raised to 110. I thought this was related to anxiety of getting the vaccine. My heart rate went back down to 84 within a minute. Then I felt fine, just tired so I did not report this feeling to anyone at the time. 25 minutes after receiving the vaccine, my Heart rate raised to 139-145, felt dizzy, numbness of nose and upper lip. Was in transit when this occurred. Pulled into a parking lot and rested. Heart rate decreased to 96. I called family to come pick me up. On the way hame I continued to feel tired and dizzy but my heart rate decreased to 96. By 11:45, I felt better just continued to be tired. Been working overtime so I was already feeling tired before receiving the vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Immunisation anxiety related reaction, Impaired driving ability
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine  4 minutes after the injection, my heart felt like it skipped a beat and my heart rate raised to 110. I thought this was related to anxiety of getting the vaccine. My heart rate went back down to 84 within a minute. Then I felt fine, just tired so I did not report this feeling to anyone at the time. 25 minutes after receiving the vaccine, my Heart rate raised to 139-145, felt dizzy, numbness of nose and upper lip. Was in transit when this occurred. Pulled into a parking lot and rested. Heart rate decreased to 96. I called family to come pick me up. On the way hame I continued to feel tired and dizzy but my heart rate decreased to 96. By 11:45, I felt better just continued to be tired. Been working overtime so I was already feeling tired before receiving the vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast milk discolouration, Muscular weakness, Pruritus, Throat irritation
Clinical narrative: patient was vaccinated at approximately 12:40 and began having an itchy face and itch throat at 1:30.  Patient is breastfeeding and decided she was going to pump and toss her milk due to getting vaccine.  When pumping she noticed that her milk was blue in color.  Today patient is feeling achy, joint and legs week.  States she feels like when she had COVID in July.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: Nausea and tingling sensation in both legs
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Nausea, Vertigo
Clinical narrative: About 6am morning of 12/24 Dizziness , vertigo, extreme fatigue, nausea and vomiting ( 3 times) injection site pain    May go to ER if condition gets worst or unable to keep anything down. Took zofran twice but has since thrown it up
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: About 6am morning of 12/24 Dizziness , vertigo, extreme fatigue, nausea and vomiting ( 3 times) injection site pain    May go to ER if condition gets worst or unable to keep anything down. Took zofran twice but has since thrown it up
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Nausea, Pain
Clinical narrative: Developed chills, fever 100.6, achy, nausea, hurt to move several days, sleepiness, fatigue, achy joints. Fever broke 12/19/20. 1/20/20 fever 99.3. 12/24/20 Working but still fatigued.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Developed chills, fever 100.6, achy, nausea, hurt to move several days, sleepiness, fatigue, achy joints. Fever broke 12/19/20. 1/20/20 fever 99.3. 12/24/20 Working but still fatigued.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Cough, Fatigue, Headache
Clinical narrative: day after the vaccine, her arm started to hurt, the pain is radiating to the back.  Fatigue Headache congestion cough weakness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Respiratory tract congestion
Clinical narrative: day after the vaccine, her arm started to hurt, the pain is radiating to the back.  Fatigue Headache congestion cough weakness
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left sided facial numbness (ear, oracle, earlobe, cheek, jaw).Timeframe going on 25 hours and not yet resolved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Product preparation error
Clinical narrative: On administering Pfizer-BioNTech COVID-19 Vaccine  12/15/20 at 9:15 PM to recipient staff member, vaccinator did not dilute vial and administered undiluted vaccine, resulting in an estimated 5 -fold increase over the intended dose and at an increased concentration.  The error was nearly immediately recognized and disclosed to the recipient staff member. They were observed for adverse reactions and before leaving the clinic they were counseled to immediately report and seek medical attention for any serious signs or symptoms.  A follow up phone call was made the following morning 12/16/20 with soreness at the injection site being the only reported reaction.  They returned to work on 12/17/20 with no additional reported signs or symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash, Urticaria
Clinical narrative: Rash, hives and redness, and swelling of the arms that soon improved with benadryl
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness, light headedness, feeling faint. Lasted 1 day. Better with food and water, Tylenol and Ibuprofen alternating every 4 hours, rest.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye discharge, Eye irritation, Eye pain, Eye swelling
Clinical narrative: The morning after the vaccine I had a sore arm, severe headache, 120 HR and felt achy all over.  I took tylenol and felt a little better.  Sunday my eye irritation began in the right eye.  The right eye was hurting, had a little drainage and was severely swollen.  Conjuctivitis set up in the right eye and the right side of my head hurted really bad with the right eye area throbbing.  Contacted my PCP who prescribed eye drops for me.  My eye is still a little swollen and my head still feels really strange and still hurts a little on the right side.  I have consulted with the NP and the PCP who is currently monitoring the situation
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: The morning after the vaccine I had a sore arm, severe headache, 120 HR and felt achy all over.  I took tylenol and felt a little better.  Sunday my eye irritation began in the right eye.  The right eye was hurting, had a little drainage and was severely swollen.  Conjuctivitis set up in the right eye and the right side of my head hurted really bad with the right eye area throbbing.  Contacted my PCP who prescribed eye drops for me.  My eye is still a little swollen and my head still feels really strange and still hurts a little on the right side.  I have consulted with the NP and the PCP who is currently monitoring the situation
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: 90 minutes post injection experienced numbness and tingling in all extremities lasting 1 hour. Resolved in all extremities except left arm. Left arm pain radiating from shoulder to forearm became severe. She sought treatment 12/23/2020 PM at a hospital emergency room where she received IV fluids and IV Toradol. On 12/24/2020 the pain persists but has improved with continued Ibuprofen 600mg every 6 hours and a sling for support.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Patient had an elevated temperature.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Soreness in injection site, headache, and tiredness.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Rhinorrhoea
Clinical narrative: Works in an ER. Got COVID vaccine - 2 days ago. + Coughing, + Rhinorrhea/ nasal congestion
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: 1300: Pain to L upper arm 1400: increasing pain to L upper arm 1600: increasing pain from shoulder to elbow  1630: face feels hot, mild sweating, temp of 100.3  1700: fatigue, exhaustion; pain in L arm extends to forearm, pain with lifting L arm  2000: rotating between episodes of chills and sweating   0700 on 12/24/20: continued fatigue; no longer have chills/sweating/fever; significant decrease to L arm pain