chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Mobility decreased, Nausea, Pain, Pain in extremity
Clinical narrative: horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood chloride decreased, Blood sodium decreased, Electrocardiogram abnormal, Laboratory test normal, Nausea
Clinical narrative: Patient, a 44 year old female received Moderna vaccine in L deltoid on 1/5/2021. On 1/6/2021, pt reported to vaccine clinic at 1130 with c/o racing heart and nausea. VS obtained. EMS called and patient transported to ER. Macular rash noted on chest per ER report. During time at ER, pt given IV fluids and PO Tylenol 1,000mg. Pt discharged home in stable condition with recommended follow up with PCP.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Palpitations, Rash, Sinus tachycardia, Urine analysis
Clinical narrative: Patient, a 44 year old female received Moderna vaccine in L deltoid on 1/5/2021. On 1/6/2021, pt reported to vaccine clinic at 1130 with c/o racing heart and nausea. VS obtained. EMS called and patient transported to ER. Macular rash noted on chest per ER report. During time at ER, pt given IV fluids and PO Tylenol 1,000mg. Pt discharged home in stable condition with recommended follow up with PCP.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient passed away after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse.  An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular  into the right arm on 07Jan2021 at 0.3 mL, single for covid-19 immunization.  There was no medical history and no concomitant medications.  On 08Jan2021, the patient passed away after receiving the COVID vaccine.  The patient died on 08Jan2021.  An autopsy was not performed. Investigations indicate that unspecified labs were done, but nothing two weeks prior; no further details were provided. The patient received the first dose the day prior. The reporting nurse discussed it with the medical director, and he thought that he potentially passed away from the COVID vaccine. The relatedness of the event to the suspect vaccine was reported as related by the reporting nurse per The Agency.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the limited information available, it is medically not possible to make meaningful causality assessment, it is unlikely the vaccine could have contributed to the death of the patient based on the known safety profile. However case will be reevaluated when additional information is received during the follow-up  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Stated that the patient passed away after receiving the Covid vaccine
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Body aches, chills, fever, fatigue.  Treatment  include Tylenol and Motrin. Fever resolved
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Sleep disorder
Clinical narrative: Received 2nd dose of Covid vaccine yesterday. Woke up at 4AM with chills, a mild headache, and arm pain. Ibuprofen helped to relieve symptoms. Still feels chills, arm pain, and now fatigue.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: Moderna COVID-19 Vaccine  On day 9 after the vaccine I have  a 2 inch red rash at the injection site with slight pain. This is new as of today. No prior rash.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Approximately 6:00 pm on 1/11/21 began experiencing muscle aches and fatigue.  On 1/12/21 these continued but became progressively worse with headache starting around noon. By 3;30 pm, symptoms were: fatigue, muscle pain, severe headache.  Body chills around 6 pm and temperature at 7 pm was 100.5.   By 6:00 am on 1/13, all symptoms resolved.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Presyncope
Clinical narrative: Fever,chills, body ache, headache, fatigue, near syncope
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever,chills, body ache, headache, fatigue, near syncope
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glossodynia, Oropharyngeal pain
Clinical narrative: experienced a sore throat, sore tongue, and very fatigued on Saturday after having
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Within 10 minutes after vaccination was given, pt developed a hive reaction that started at the injection site and spread to top of chest and lower neck, continued to spread up 45 minute post vaccine.  Pt was evaluated by  NP - BP 134/89, pulse 90.  (2) 25mg  oral benedryl were administered & 1 claritin tab.  At90 minute post vaccination, hives rash had resolved.  No other S/sx were noted.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Headache, Pain in extremity, Pyrexia
Clinical narrative: Estimated due date:  Unknown - around 08/15/2021 - 1st OB appt on 01/12/2021 -  I started having a headache on Thursday and chills and I checked my temp and it was 100.1F I monitored it and it was slowly climbing up. It hit 100.4F and I went home and it was 100.8F around 5PM I took a gram of Tylenol and few hours later headache and fever resolved and I felt completed normal after that. Next day all was back to normal but my arms hurt a lot the next day.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hypertension, Paraesthesia, Paralysis
Clinical narrative: 10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Choking sensation, Eyelid function disorder, Heart rate increased, Palpitations
Clinical narrative: 10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Paralysis, Speech disorder
Clinical narrative: 10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: swelling and redness at the site with warmth to touch and red streaking starting . Soreness to left arm since 1/11/2021.  Redness and swelling noted on 1/13/2021
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: swelling and redness at the site with warmth to touch and red streaking starting . Soreness to left arm since 1/11/2021.  Redness and swelling noted on 1/13/2021
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: pts deltoid noticed significant swelling 4x4 inches
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Sensation of foreign body
Clinical narrative: At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Used medication for asthma. Flovent inhaler for 5 times. Used xyzal 5mgs via oral. These medications are used by doctor's orders.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lip swelling, Peripheral swelling, Urticaria
Clinical narrative: Swelling of wrist, hands and lips. Hives
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue. Started all of a sudden. Went to sleep early and took a naproxen and it resolved.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: pink skin around injection site approximately 2 inches in diameter, soft, mild warmness.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Full blood count, Laboratory test, Skin warm
Clinical narrative: Patient had sudden onset of flushing/erythema of skin (no pruritus, but warm to touch), diaphoresis, and itchy throat.  She denies shortness of breath or any respiratory problems. Symptoms started 20 min prior to arrival at the Emergency Department. When the patient arrived at the ED, all of her signs and symptoms had started to subside.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: Patient had sudden onset of flushing/erythema of skin (no pruritus, but warm to touch), diaphoresis, and itchy throat.  She denies shortness of breath or any respiratory problems. Symptoms started 20 min prior to arrival at the Emergency Department. When the patient arrived at the ED, all of her signs and symptoms had started to subside.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient received her vaccination on 1/12/21 administered by pharmacy*+. She expired on 1/12/21 an approximately 7:30pm. Resident did not have any adverse reactions and was a hospice patient.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Cough, Feeling cold, Headache
Clinical narrative: Pt received COVID19 Vaccine (Moderna) at 9am 1/8/2021.  -Pt completed 15 min observation and then returned to work.  -Pt came back at 12:30 with the following symptoms: stomach pain, nausea, shivering, feeling very cold, headache, "sleepiness" of his left arm (same arm as the shot), itchy throat, cough, and feeling very thirsty.  -Pt reports his headache as very painful, b/l, and feeling as if his head was very "hot." Pt has no hx of headaches.  -Nausea in and out, never vomited.  -Denied dizziness, change in vision, shortness of breath, difficulty breathing, chest pain, difficulty swallowing, rash, lightheadedness.  -Pt did not eat anything all morning.  -Took vitals, blood glucose (see vitals section). High BP and pulse. Sugar: 169 -Pt given Benadryl 25mg IM (on opposite side of vaccine).  -Pt took 500mg Tylenol and then a few hours later 500mg more Tylenol (on own accord). -Pt observed 12:30-4:30. Slept off and on. Felt a lot better at 4:30. Pt discharged.  -Pt was also seen and evaluated by MD.   -Of note, pt does not have any allergies that he is aware of.  -Has "pre HTN and pre diabetes." -Hx of heart disease - father CABG, in mid 40s.   -Pt was observed for 4 hours.  -BP  went down after pt calmed down a little bit and was given Benadryl and Tylenol.  -Pulse was also very high, but then decreased throughout observation (see VITALS section). -Pt feeling fine at 4:30 and discharged.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Nausea, Thirst, Throat irritation
Clinical narrative: Pt received COVID19 Vaccine (Moderna) at 9am 1/8/2021.  -Pt completed 15 min observation and then returned to work.  -Pt came back at 12:30 with the following symptoms: stomach pain, nausea, shivering, feeling very cold, headache, "sleepiness" of his left arm (same arm as the shot), itchy throat, cough, and feeling very thirsty.  -Pt reports his headache as very painful, b/l, and feeling as if his head was very "hot." Pt has no hx of headaches.  -Nausea in and out, never vomited.  -Denied dizziness, change in vision, shortness of breath, difficulty breathing, chest pain, difficulty swallowing, rash, lightheadedness.  -Pt did not eat anything all morning.  -Took vitals, blood glucose (see vitals section). High BP and pulse. Sugar: 169 -Pt given Benadryl 25mg IM (on opposite side of vaccine).  -Pt took 500mg Tylenol and then a few hours later 500mg more Tylenol (on own accord). -Pt observed 12:30-4:30. Slept off and on. Felt a lot better at 4:30. Pt discharged.  -Pt was also seen and evaluated by MD.   -Of note, pt does not have any allergies that he is aware of.  -Has "pre HTN and pre diabetes." -Hx of heart disease - father CABG, in mid 40s.   -Pt was observed for 4 hours.  -BP  went down after pt calmed down a little bit and was given Benadryl and Tylenol.  -Pulse was also very high, but then decreased throughout observation (see VITALS section). -Pt feeling fine at 4:30 and discharged.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Hypoaesthesia, Lymphadenopathy, Pain, Paraesthesia
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my vaccine and when I arrived home about 1pm that day My leg felt odd.  when walking, standing I felt an odd sensation in my left foot/lower calf area.  I had body aches mild which progressed at night especially pain running down my left side of my body.   The next morning I put on my clothes for work and my body still mild aches but the pant leg was tight especially around the calf.  My My left foot was swollen as well as my shoe fit tighter.  I also had a numbing sensation through the leg.  I had an ache behind the calf and the heel of my foot as well as the left foot of my left foot.  The swelling remained and I worried I might have a DVT.  I called my primary care DR office and they said I should go to the ER.  I called employee health at my job and they told me go to the ER.  So on 12/29/2020 I went to the ER.  The providers there also thought I had a DVT especially after examining my leg and recognizing the significant swelling.  My US venous doppler showed negative for DVT however a significantly enlarged lymph node.  As of today the swelling is much improved however still slight.  The sensation in my left foot is still not the same as before.  I have a numbness and tingling sensation that runs from my Left lateral calf down to the sole of my foot.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Ultrasound Doppler
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my vaccine and when I arrived home about 1pm that day My leg felt odd.  when walking, standing I felt an odd sensation in my left foot/lower calf area.  I had body aches mild which progressed at night especially pain running down my left side of my body.   The next morning I put on my clothes for work and my body still mild aches but the pant leg was tight especially around the calf.  My My left foot was swollen as well as my shoe fit tighter.  I also had a numbing sensation through the leg.  I had an ache behind the calf and the heel of my foot as well as the left foot of my left foot.  The swelling remained and I worried I might have a DVT.  I called my primary care DR office and they said I should go to the ER.  I called employee health at my job and they told me go to the ER.  So on 12/29/2020 I went to the ER.  The providers there also thought I had a DVT especially after examining my leg and recognizing the significant swelling.  My US venous doppler showed negative for DVT however a significantly enlarged lymph node.  As of today the swelling is much improved however still slight.  The sensation in my left foot is still not the same as before.  I have a numbness and tingling sensation that runs from my Left lateral calf down to the sole of my foot.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest pain, Cough, Pain, Pruritus
Clinical narrative: Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl.  This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl.  This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy, Pain, Swelling, Tenderness
Clinical narrative: Discomfort and pain associated with a soft, swollen, tender lump with no erythema located under the left ventral supraclavicular skin.
Age: 45.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal discomfort, Rash erythematous
Clinical narrative: Patient with significant erythematous reaction to left deltoid ~ 13x20 cm in size.  Progressively increasing in size. Tx for concern of cellulitis vs. localized reaction due to Prevnar 13.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: Patient four months old, kinrix was given inadvertently. Medication error
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Cardiac arrest, Cardio-respiratory arrest, Death, Pulse absent
Clinical narrative: Patient was found "acting abnormal" on 1/9/2021 at 1215. VS HR 20-30's. EMS activated. EMS arrived and patient was found pulseless in PEA/ asystole,  CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation  and expired on 1/09/2021 at 1348. Clinical impression Cardiopulmonary arrest.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Resuscitation
Clinical narrative: Patient was found "acting abnormal" on 1/9/2021 at 1215. VS HR 20-30's. EMS activated. EMS arrived and patient was found pulseless in PEA/ asystole,  CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation  and expired on 1/09/2021 at 1348. Clinical impression Cardiopulmonary arrest.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Injection site erythema, Injection site induration
Clinical narrative: 2 hours post injection patient vocalized lower abdominal discomfort accompanied by multiple episodes of diarrhea following day diarrhea subsides but patient notes lethargy, blurred vision, chills/fever (max 102) and itchy, tender,  red induration to left deltoid at injection site. Induration has enlarged to current 11cmx9cm in size.  Area marked for monitoring
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Lethargy, Pyrexia, Vision blurred
Clinical narrative: 2 hours post injection patient vocalized lower abdominal discomfort accompanied by multiple episodes of diarrhea following day diarrhea subsides but patient notes lethargy, blurred vision, chills/fever (max 102) and itchy, tender,  red induration to left deltoid at injection site. Induration has enlarged to current 11cmx9cm in size.  Area marked for monitoring
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Insomnia
Clinical narrative: 2 dose, feeling of being cold, not able to warm up, unable to sleep
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Urinary retention
Clinical narrative: Recipient reported sudden worsening of urinary retention following the 1st dose of Covid19 vaccine.   The symptoms did resolve within 24 hours and did not reoccur with the second dose administration.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: The day after receiving my 2nd COVID shot I had experienced whole body aches for a period of approximately 12-14 hours
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Injection site pain, Myalgia
Clinical narrative: PAIN INJECTION SITE,TIRE,MUSCULAR PAIN,JOINT PAIN,COUGH AND TARDICARDIAC.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: PAIN INJECTION SITE,TIRE,MUSCULAR PAIN,JOINT PAIN,COUGH AND TARDICARDIAC.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Injection site pain, Pain
Clinical narrative: 24 hr after vaccine developed body aches in shoulders, hip and back.  Moderate to severe fatigue and sore left arm at site of injection.  Symptoms remained for 36 -48 hrs.  Took Tylenol for body aches , increased fluid intake and rested for 2 days.  Completely resolved by day 3
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Systemic: Sweating
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Optic neuritis
Clinical narrative: optic neuritis; loss of vision; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 56 years old. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 16-NOV-2015, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a primary care facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: optic neuritis and loss of vision. The outcome of the events was not provided. The reporter considered the events of optic neuritis and blindness to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of optic neuritis and blindness were determined to be medically significant.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Fibromyalgia, Hypoacusis
Clinical narrative: hearing issues; fibromyalgia; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 64 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 06-DEC-2012, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: hearing issues and fibromyalgia. The outcome of the events was not provided. The reporter considered the events of hypoacusis and fibromylagia to be related to zoster vaccine live (ZOSTAVAX).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported.; Nurse reported a dose of expired VARlVAX (found supported) was given to a patient on 01/06/2021.; This spontaneous report was received from a nurse, referring to a 12-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 06-JAN-2021 (conflicting information also reported as "06-JAN-2020") , the patient was vaccinated with a expired dose (expired product administered) of varicella virus vaccine live (oka/merck) (VARIVAX), administered at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not provided; lot number R034394, which has been verified to be valid, expiration date reported and validated as 27-NOV-2020). There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received 1 ML dose instead of the recommended .5ML; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) received 1 ML dose instead of the recommended .5ML.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received his first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient received a 1 ml dose instead of recommended 0.5 ml. The patient hadn't had a reaction.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, received 1 ML dose instead of the recommended .5ML, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a  male patient of unknown age. The patient's medical history is not provided. The patient experienced an unexpected event of inappropriate dose of vaccine administered (1ml instead of recommended 0.5ml).  The event occurred on 29 Dec 2020 during the administration of first dose of mRNA-1273. The patient did not have the reaction. The sponsor considered the event as not related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received approximately 0.1mL; A spontaneous report was received from pharmacist concerning a male patient, who received Moderna's COVID-19 vaccine and received approximately 0.1mL.  The patient's medical history was not reported. Concomitant medication use was not reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 23 Dec 2020, there was a malfunction with the needle so the patient received less than 0.5mL of the vaccine. The reporter believes the needle was not on correctly and the administration error was due to user error. The nurse noticed 0.4 left in the syringe, so the reporter believes the patient received approximately 0.1 mL of the vaccine. The vaccine did not leak on the provider and the needle fell onto the floor during administration. The patient did not contact his healthcare provider and has not reported any adverse reactions or symptoms during administration. Treatment information was unknown.   Action taken with mRNA-1273 in response to the event was unknown.   The event, received approximately 0.1mL, was considered resolved on 23 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported AEs associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patients under the age of 18 were administered a COVID vaccine; A spontaneous report was received from a pharmacist concerning a 17 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced patients under the age of 18 were administered a COVID vaccine.   The patient's medical history was not provided. No concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026-20A).   On 29 Dec 2020, the vaccine was administered to a 17-year-old patient.   The action taken with mRNA-1273 in response to the event was unknown.  The outcome for the event, patients under the age of 18 were administered a COVID vaccine, was considered recovered on 29 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273 (Lot number: 026-20A). There were no reported AEs associated with this case.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Constipation, Dizziness, Headache, Hypoaesthesia
Clinical narrative: 5 days after administration- heavy uterine bleeding; constipation; severe knee/shoulder joint pain; light sensitivity; dizziness/ light headedness; thigh numbness; pain when prodded on either sides of thighs; harsh headache; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received BNT162B2 first dose on 31Dec2020 03:15 PM intramuscularly on left arm at single dose for COVID-19 immunization. Medical history included Depression, Anxiety, Factor V Leiden, Known allergies to Penicillin and Onion sensitivity. Patient is not pregnant. No other vaccine in four weeks. Concomitant medications in two weeks included unspecified medications. "5 days after administration" (also reported as 01Jan2021)- heavy uterine bleeding (resulting with trip to ER), constipation, severe knee/ shoulder joint pain, light sensitivity, dizziness/ light headedness, thigh numbness, pain when prodded on either sides of thighs, harsh headache. No treatment received for the events. Events resulted in ER and physician office visit. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered. The seriousness was reported as no.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported uterine bleeding cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Photophobia, Uterine haemorrhage
Clinical narrative: 5 days after administration- heavy uterine bleeding; constipation; severe knee/shoulder joint pain; light sensitivity; dizziness/ light headedness; thigh numbness; pain when prodded on either sides of thighs; harsh headache; This is a spontaneous report from a contactable Other healthcare professional (patient). A 21-year-old female patient received BNT162B2 first dose on 31Dec2020 03:15 PM intramuscularly on left arm at single dose for COVID-19 immunization. Medical history included Depression, Anxiety, Factor V Leiden, Known allergies to Penicillin and Onion sensitivity. Patient is not pregnant. No other vaccine in four weeks. Concomitant medications in two weeks included unspecified medications. "5 days after administration" (also reported as 01Jan2021)- heavy uterine bleeding (resulting with trip to ER), constipation, severe knee/ shoulder joint pain, light sensitivity, dizziness/ light headedness, thigh numbness, pain when prodded on either sides of thighs, harsh headache. No treatment received for the events. Events resulted in ER and physician office visit. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered. The seriousness was reported as no.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported uterine bleeding cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hypoaesthesia oral, Lip swelling, Swollen tongue, Throat clearing
Clinical narrative: Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start having bulbar reaction with clearing of throat and tightness of chest; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; This is a spontaneous report from a contactable Other-HCP (patient herself).  This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 07Jan2021 at 14:15 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 48-year-old. The patient was not pregnant. No other vaccine was received in four weeks.Relevant medical history included COVID 19 complications (prior to vaccination). The patient has allergy to contrast dye, sulfa and molds. Relevant concomitant medications included nebivolol hydrochloride (BYSTOLIC), topiramate (TOPAMAX), atorvastatin (LIPITOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), and acetylsalicylic acid (ASA). After vaccination, within 5 min she started with numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation. Began to start having bulbar reaction with clearing of throat and tightness of chest. She was given diphenhydramine hydrochloride (BENADRYL) total 50 mg, famotidine (PEPCID) 20 mg, dexamethasone (DECADRON) 4 mg and racemic epinephrine. The events required visit at emergency room/department and urgent care. However, the events were reported as non-serious by the reporter. Post-vaccination COVID test was not performed. The patient had not recovered from the events.; Sender's Comments: The reported "numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation", "bulbar reaction with clearing of throat and tightness of chest" developed within 5 min administration of BNT162B2, is likely an allergic reaction to BNT162B2, and considered related.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Palpitations
Clinical narrative: My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitations; Feeling of lightheadedness; This is a spontaneous report from a contactable nurse reporting for herself. A 50-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration in the right arm on 29Dec2020 at 12:15 pm, at 50-years of age, at single dose for COVID-19 immunization. The patient received the vaccine in Hospital and didn't receive any other vaccine in the previous four weeks. Medical history included hypertension from an unknown date (controlled) and no known allergy. Concomitant medication included amlodipine besilate 10 mg (NORVASC). The patient reported that, on 29Dec2020, within 6 minutes after receiving the vaccine dose, her heart started racing, it was noted at 133, her blood pressure shot up as well to 180/107, she had strong heart palpitations with feeling of lightheadedness. Prior to the vaccine the patient was at work, feeling well and taking care of her patients. Emergency Room visit and Physician Office visit were required, moreover fluids and potassium were administered to the patient as a result of the events. She reported she spent 8 hours in the ER. The events were reported as non-serious but they were assessed as important medical events by the Company. At the time of the report the reported events were resolving.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hypertensive crisis, Palpitations, and Lightheadedness cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Feeling abnormal
Clinical narrative: Patient admitted for a fib; This is a spontaneous report from a contactable consumer. A female patient in her 70s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was unknown, via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and  concomitant medications were not reported. It was reported that the patient received vaccine on Tuesday, 05Jan2021. On Thursday, 07Jan2021, patient did not feel good-pulse and blood pressure. It was mentioned that the patient admitted for a fib. Two days after receiving Pfizer-BioNTech Covid 19 vaccine, the woman patient in her 70s was admitted for a fib.  Information about lot/batch number has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: get very sick right after every year; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a female patient of unknown age who get very sick right after every year (Illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, the patient had got very sick right after every year (Illness).  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Abdominal discomfort
Clinical narrative: screwed my stomach; Initial information regarding an unsolicited valid non-serious case received from a consumer via social media and transmitted to Sanofi on 09-Dec-2020.  This case involved an unknown age patient who experienced screwed my stomach (Abdominal discomfort), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported.  On unknown date, (latency unknown) patient reported the last time patient got a flu shot it totally screwed stomach up, patient stomach hasn't been right ever since would never allow another shot to be stuck in arm for any reason (Abdominal discomfort).  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine Patient received 2nd dose of Pfizer-BioNTech vaccine on 1/8/2021 at 8:23am and 5 minutes later she experienced palpitations. HR 150 -190.  Sent to ED for evaluation at 8:37am.  In ED, her HR was in the 90s and patient feeling better.  BP 134/95. No further treatment. Patient discharged at 9:13am
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate affect, Tinnitus, Vital signs measurement
Clinical narrative: Felt slightly dizzy right after getting vaccine and felt an ?adrenalin rush? but these symptoms resolved after about 9 minutes.  Then was preparing to leave the observation area at about 1030 her ears started ringing.  Ringing is constant and prominent.  It so far is not getting any better.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus, Pain, Pain in extremity
Clinical narrative: Sore arm, ache, headache for 2 days after vaccine. Vaccine site was firm to touch and slightly itchy for a week or so. As of 1/12/2021 a red ring approx. 2 inches in diameter appeared around the vaccine site. Began to fade as of 1/13/2021
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Sore arm, ache, headache for 2 days after vaccine. Vaccine site was firm to touch and slightly itchy for a week or so. As of 1/12/2021 a red ring approx. 2 inches in diameter appeared around the vaccine site. Began to fade as of 1/13/2021
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Extreme fatigue, mild headache, swelling and extreme soreness at injection site
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Vaccination site mass, Vaccination site pain
Clinical narrative: Extreme fatigue, mild headache, swelling and extreme soreness at injection site
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Pain in extremity, Rash
Clinical narrative: 1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong patient
Clinical narrative: Error: Wrong Patient (documentation in EMR); symptoms lasted 0 days
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Injection site pruritus, Injection site warmth, Skin warm
Clinical narrative: There was itching and warmth at the injection site initially. Dizziness was noticed two times that week.  The itching continued and became increasingly worse.  Then, in addition to the moderate itching, there was a welt, swollen with redness and warm to the touch.  The welt grew in size.  Treatment included going to an Immediate Care where I received a steroid injection, steroid cream and a Medrol pack.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: There was itching and warmth at the injection site initially. Dizziness was noticed two times that week.  The itching continued and became increasingly worse.  Then, in addition to the moderate itching, there was a welt, swollen with redness and warm to the touch.  The welt grew in size.  Treatment included going to an Immediate Care where I received a steroid injection, steroid cream and a Medrol pack.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors to all extremities (for about 10 mins) and chills the night after getting the vaccine.  tongue numbness happens to her at baseline at times, this has subsided The tremors started after stretching her arms, they stopped shaking after about 10 mins after she laid in bed.  Temp was about 100-101.2 through the night  Has not taken any medications for this.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia, Tremor
Clinical narrative: Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors to all extremities (for about 10 mins) and chills the night after getting the vaccine.  tongue numbness happens to her at baseline at times, this has subsided The tremors started after stretching her arms, they stopped shaking after about 10 mins after she laid in bed.  Temp was about 100-101.2 through the night  Has not taken any medications for this.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dysstasia, Lethargy
Clinical narrative: Employee complained of dizziness after sitting for 10 min in observation area. Employee became lethargic  and  was unable to stand. She  complained of R side chest pain and R sided weakness. Symptoms did not go away. Employee sent to ER.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Weird taste in mouth