chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Headache  Muscle pain Chills Fever 100.8 Fever 103.4 Nausea Swollen lymph nodes  Night sweats  Took Tylenol which helped some
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: Headache  Muscle pain Chills Fever 100.8 Fever 103.4 Nausea Swollen lymph nodes  Night sweats  Took Tylenol which helped some
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Paraesthesia oral, Pityriasis rosea, Rash, SARS-CoV-2 test
Clinical narrative: Almost immediately after the shot I could feel it/taste it in my mouth. I had some swelling/tingling of the tongue mouth. They had me wait the additional 15 mins. Did the pulse/ox. I was normal. Advised to take antihistamine, which I did when I got home. Felt better that day.   On Friday, Jan. 29 I noticed a rash on my torso - stomach, back from bra line down to buttocks. I texted a pic to my friend who is a pediatrician. She said it looked pityriasis rosea. It doesn't itch. I also began having tingling on my tongue again. As of today, 2/2, I still have the rash and some tingling on the tongue.  I've been taking a generic claritan in the morning and a benadryl in the afternoon and before bed. I also received a notice at work on Friday and a phone call from the county on Saturday that I may have been exposed to covid on Jan. 26. I have had none of the symptoms typical of covid. Just the rash and the tongue tingling.  I called the number today. They advised I complete this form. I am getting a covid test tonight.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Taste disorder
Clinical narrative: Almost immediately after the shot I could feel it/taste it in my mouth. I had some swelling/tingling of the tongue mouth. They had me wait the additional 15 mins. Did the pulse/ox. I was normal. Advised to take antihistamine, which I did when I got home. Felt better that day.   On Friday, Jan. 29 I noticed a rash on my torso - stomach, back from bra line down to buttocks. I texted a pic to my friend who is a pediatrician. She said it looked pityriasis rosea. It doesn't itch. I also began having tingling on my tongue again. As of today, 2/2, I still have the rash and some tingling on the tongue.  I've been taking a generic claritan in the morning and a benadryl in the afternoon and before bed. I also received a notice at work on Friday and a phone call from the county on Saturday that I may have been exposed to covid on Jan. 26. I have had none of the symptoms typical of covid. Just the rash and the tongue tingling.  I called the number today. They advised I complete this form. I am getting a covid test tonight.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Injection site pain, Injection site swelling, Muscle spasms
Clinical narrative: Pain an swelling around shot area.  Weakness, Muscle Pain Headache Leg cramps   Lasted about 24 Hours.After that time it gradually subsided.   Tjis was on Friday and It was gone by Monday
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Pain an swelling around shot area.  Weakness, Muscle Pain Headache Leg cramps   Lasted about 24 Hours.After that time it gradually subsided.   Tjis was on Friday and It was gone by Monday
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: An itchy rash appeared at my injection site about a week after the vaccine. It was a circular, red rash.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site irritation
Clinical narrative: injection site red irritated
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: On the same day of vaccine in the night I started to have chills & body ache. They lasted through the next day they lasted for about 18hrs.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The Covid 19 vaccine was given to a 17 year old female.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash pruritic, Vaccination site rash
Clinical narrative: Redness, itchy rash erupted on 1/28/21 on the upper left arm where vaccine was administered.  Resident reported event today 2/2/21 to nurse at assisted living.  Resident stated that this is 2 weeks and 2 days after being vaccinated.  Resident does not report any other symptoms.  Daughter will be notifying medical provider.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: injection site red irritated
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: pt states a week after the covid vax she noticed her left arm is warm and swollen around the injection site.  Pt said she will contact PCP to let them know about her symptoms.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: injection site red irritated
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: Chills, Fever, Breathing, Weakness, Headache.  This started in afternoon 1 day after receiving vaccine.  Took 2 Tylenol 4 hours later took 2 Advil.  Chills went away.  Had a fever , but this morning it is gone.  I have never had a reaction to any kind of vaccination before exept for a minor sore arm.  If I had a reaction to the first one, should I have a reaction to the second does also?
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site rash, Myalgia, Pain, Pyrexia
Clinical narrative: slight fever, headache, body/muscle aches and local injection site reaction (rash). Symptoms did not appear until about 14 hours post vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Erythema, Feeling jittery, Flushing
Clinical narrative: Over an hour later patient was at lunch when she developed a flushed feeling, felt a little dizzy. Went to the bathroom and saw her eyes bloodshot red, chest red and flushed. She notified other healthcare worker and was signed in immediately to see physician. No sob but felt pressure on her chest and felt jittery inside her body. She frequently was clearing her throat which her fellow associates said she was not doing prior to injection. Was treated with NS bolus and medications and was discharged home. Doctor wants her to stay out of work tomorrow.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Throat clearing
Clinical narrative: Over an hour later patient was at lunch when she developed a flushed feeling, felt a little dizzy. Went to the bathroom and saw her eyes bloodshot red, chest red and flushed. She notified other healthcare worker and was signed in immediately to see physician. No sob but felt pressure on her chest and felt jittery inside her body. She frequently was clearing her throat which her fellow associates said she was not doing prior to injection. Was treated with NS bolus and medications and was discharged home. Doctor wants her to stay out of work tomorrow.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: injection site red irritated
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever x 2 days, severe dizziness, headache, nausea, fatigue. Dizziness, fatigue, and headache, while reduced, are still present on day after vaccine administration.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient has redness on injection site 1 week after receiving the vaccine. Patient states is warm to touch and is slowly going down and has applied ice to the area.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pyrexia
Clinical narrative: Day after vaccine developed fever, chills, body aches temp 100.2 F lasted for 4-5 hours.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Injection site erythema, Oral pain, Paraesthesia oral
Clinical narrative: Red circle, appx. 1 1/2 inch diameter on upper left shoulder in area of Vaccine administered.  Tingling and pain in mouth and gums
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Aggression, Apparent life threatening event, Delusion, Diet refusal, Mental disorder
Clinical narrative: Delusional and confrontational; Unable to take meds or eat; Seemed to be having a mental breakdown; Constantly obsessing over minutia that was not pertinent to what she is being asked to do; She gets very upset and anxious and angry; This is a spontaneous report from a contactable nurse. An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular (left arm) on 15Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included depression, cerebrovascular accident (CVA), chronic heart failure (CHF), emphysema, and angina, all from unknown dates and unknown if ongoing. Concomitant medication included furosemide (LASIX), amlodipine, losartan, sertraline, nortriptyline, methazolamide, quetiapine fumarate (SEROQUEL), dorzolamide, tiotropium bromide (SPIRIVA), ciclesonide (ALVESCO), albuterol (ALBUTEROL [SALBUTAMOL]), carvedilol, calcium magnesium, iron, curcuma longa (TURMERIC), clarithromycin (CLARITIN), magnesium citrate, cyanocobalamin (B 12), paracetamol (TYLENOL), estradiol (ESTRACE) , d-mannose, vitamin D3. Concomitant medication also includes multivitamin, and stool softeners. It was reported that on 15Jan2021 at 15:30 the patient became delusional and confrontational and unable to take meds or eat. The patient seemed to be having a mental breakdown. No physician (MD) in ER would address the issue. It happened approximately two hours after the vaccine. She will not eat or take meds; she is constantly obsessing over minutia that was not pertinent to what she is being asked to do. For example, she comes up with steps she needs to take before she can eat, but she doesn't know them, so she gets very upset and anxious and angry. The events were assessed as life-threatening. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. However high age of the patient and underlying medical conditions cannot be ruled out a contributory factors 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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Refusal of treatment by patient
Clinical narrative: Delusional and confrontational; Unable to take meds or eat; Seemed to be having a mental breakdown; Constantly obsessing over minutia that was not pertinent to what she is being asked to do; She gets very upset and anxious and angry; This is a spontaneous report from a contactable nurse. An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular (left arm) on 15Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included depression, cerebrovascular accident (CVA), chronic heart failure (CHF), emphysema, and angina, all from unknown dates and unknown if ongoing. Concomitant medication included furosemide (LASIX), amlodipine, losartan, sertraline, nortriptyline, methazolamide, quetiapine fumarate (SEROQUEL), dorzolamide, tiotropium bromide (SPIRIVA), ciclesonide (ALVESCO), albuterol (ALBUTEROL [SALBUTAMOL]), carvedilol, calcium magnesium, iron, curcuma longa (TURMERIC), clarithromycin (CLARITIN), magnesium citrate, cyanocobalamin (B 12), paracetamol (TYLENOL), estradiol (ESTRACE) , d-mannose, vitamin D3. Concomitant medication also includes multivitamin, and stool softeners. It was reported that on 15Jan2021 at 15:30 the patient became delusional and confrontational and unable to take meds or eat. The patient seemed to be having a mental breakdown. No physician (MD) in ER would address the issue. It happened approximately two hours after the vaccine. She will not eat or take meds; she is constantly obsessing over minutia that was not pertinent to what she is being asked to do. For example, she comes up with steps she needs to take before she can eat, but she doesn't know them, so she gets very upset and anxious and angry. The events were assessed as life-threatening. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. However high age of the patient and underlying medical conditions cannot be ruled out a contributory factors 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation.  Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications.  Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning.  She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning.  She kind of fainted.  She was walking from one room to the next and she just gave out.  It has improved and she is not really dizzy any more.  She is having a little fatigue though. Chills began at 06:30 and they come and go.  She is going through menopause and it could have something to do with it.  She was unable to answer outcome for this. She just wants the headache to stop.  She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00.  When she first got it, she did not feel it.  As the day progressed, she could feel the pain.  Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills  07:00-07:30.  She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin, Syncope
Clinical narrative: kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation.  Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications.  Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning.  She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning.  She kind of fainted.  She was walking from one room to the next and she just gave out.  It has improved and she is not really dizzy any more.  She is having a little fatigue though. Chills began at 06:30 and they come and go.  She is going through menopause and it could have something to do with it.  She was unable to answer outcome for this. She just wants the headache to stop.  She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00.  When she first got it, she did not feel it.  As the day progressed, she could feel the pain.  Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills  07:00-07:30.  She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Short fainting spell; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1686), intramuscularly on 14Jan2021 after 15:00 (her appointment was at 1510 but she had to wait past her appointment time before she received it) in upper right arm at single dose for Prevent Covid in hospital. No history of all previous immunization with bnt162b2 considered as suspect. No additional vaccines administered on same date of bnt162b2. Medical history included breast cancer from 9 years before 19Jan2021 (2012) and she has been Anastrozole since, she was only supposed to take Anastrozole for 5 years and when she was one month away from being done with it she had a Seizure and she was found to have a Tumor in her brain, she had had Srs surgery on her brain on 13Apr2016, she was prescribed Levetiracetam, a seizure medication, for two years and had not had any problem since. Concomitant medication included ongoing anastrozole taking for about 9 years for Post breast cancer. No prior vaccinations within 4 weeks. The patient previously took levetiracetam for seizure, she stopped taking Levetiracetam 750mg about 2 or 3 years before 19Jan2021, flu shot on 05Dec2020 for immunization at the age of 66-year-old. The patient reported that she had a short fainting spell around 8:30am on 19Jan2021 and she was not sure if it was related to the Covid vaccine. She described that she had been sitting for a while and when she got up she felt like this black curtain coming down which she has felt before in the past but she usually recovered and never lost control to where she fainted. Her husband was there to catch her. She clarified that she never passed out. She did not have any reactions in the past few days since she received the covid vaccine, she did not even have soreness at injection site. The event was not required a visit to Emergency Room nor Physician Office. Relevant Tests was none. The outcome of the event was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac arrest, Decreased appetite, Dyspepsia, Dyspnoea
Clinical narrative: Narrative:  Patient experienced cardiac arrest with PEA and a witnessed collapse upon arrival to the emergency department on 1/24/21. Patient received his first dose of the COVID vaccine on 01/15/2021and felt poorly thereafter. He was describing shortness of breath to his wife and requiring 5L of O2 at home to maintain saturations in 80s, while he usually was on 3L to maintain saturations in the mid 90s. He had been oriented but more fatigued than normal and described bilateral shoulder pain (which was not new for him) as well as indigestion. Took Tylenol with some relief. He had decreased PO intake and less appetite. The patient's wife encouraged him to come to the hospital daily for a week prior to admission, but the patient did not want to because he felt his side effects were secondary to the vaccine. Symptoms:RespDepression, Palpitations, Syncope & cardiac arrest Treatment: EPINEPHRINE 1 MG ONCE 3 rounds given ,CALCIUM CHLORIDE 1000 MG ONCE
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypophagia, Palpitations, Pulseless electrical activity
Clinical narrative: Narrative:  Patient experienced cardiac arrest with PEA and a witnessed collapse upon arrival to the emergency department on 1/24/21. Patient received his first dose of the COVID vaccine on 01/15/2021and felt poorly thereafter. He was describing shortness of breath to his wife and requiring 5L of O2 at home to maintain saturations in 80s, while he usually was on 3L to maintain saturations in the mid 90s. He had been oriented but more fatigued than normal and described bilateral shoulder pain (which was not new for him) as well as indigestion. Took Tylenol with some relief. He had decreased PO intake and less appetite. The patient's wife encouraged him to come to the hospital daily for a week prior to admission, but the patient did not want to because he felt his side effects were secondary to the vaccine. Symptoms:RespDepression, Palpitations, Syncope & cardiac arrest Treatment: EPINEPHRINE 1 MG ONCE 3 rounds given ,CALCIUM CHLORIDE 1000 MG ONCE
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory depression, Syncope
Clinical narrative: Narrative:  Patient experienced cardiac arrest with PEA and a witnessed collapse upon arrival to the emergency department on 1/24/21. Patient received his first dose of the COVID vaccine on 01/15/2021and felt poorly thereafter. He was describing shortness of breath to his wife and requiring 5L of O2 at home to maintain saturations in 80s, while he usually was on 3L to maintain saturations in the mid 90s. He had been oriented but more fatigued than normal and described bilateral shoulder pain (which was not new for him) as well as indigestion. Took Tylenol with some relief. He had decreased PO intake and less appetite. The patient's wife encouraged him to come to the hospital daily for a week prior to admission, but the patient did not want to because he felt his side effects were secondary to the vaccine. Symptoms:RespDepression, Palpitations, Syncope & cardiac arrest Treatment: EPINEPHRINE 1 MG ONCE 3 rounds given ,CALCIUM CHLORIDE 1000 MG ONCE
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other information available.; Caller reports administration of ROTATEQ after temperature excursion; This spontaneous report was received from a health professional, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 18-JAN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), at a dose of 2 milliliters (ml), administered orally (po) (dose and vaccination scheme frequency were not reported; lot number 1691141, which have been verified to be a valid lot number, expiration date reported and validated as 01-NOV-2021) as prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 1.3 degrees Celsius (C) for 19 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: a temperature excursion for VARlVAX, were administered to patients; This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-JAN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0.5 milliliter (ml) (dose described as 0.5 mL SQ x 1 dose), lot # S038698, expiration date: 01-DEC-2021 (dose number, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 4 hours in the temperature 32.4 degrees Fahrenheit (F). There was no previous temperature excursion. Digital Data Logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA010369: US-009507513-2101USA010348: US-009507513-2101USA010358: US-009507513-2101USA009977:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: other zoster-related conditions; shingles; Information was received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's past medical history, concurrent conditions, and concomitant therapies were not provided. On or about 18-JUN-2012, the pt was administered the zoster vaccine live (ZOSTAVAX) vaccine (strength, lot #, expiration date, dosage, route of administration or anatomical location were not provided) by a healthcare provider at a pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a physician at a hospital, for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). The outcome of herpes zoster and ill-defined disorder was not reported.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Abdominal discomfort, Herpes zoster, Pain, Prophylaxis, Pyrexia
Clinical narrative: pAIN; Fever; Upset stomach; This case was reported by a consumer via other manufacturer and described the occurrence of generalized aching in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for ulcerative colitis.   On an unknown date, the patient received the 2nd dose of Shingrix and Humira (subcutaneous) at an unknown dose and frequency. On an unknown date, immediately after receiving Shingrix, the patient experienced generalized aching, fever and upset stomach. The action taken with Humira was unknown. On an unknown date, the outcome of the generalized aching, fever and upset stomach were unknown.   It was unknown if the reporter considered the generalized aching, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient did not have any medical history. Concomitant drugs not reported. It was reported that the patient experienced vaccination adverse reaction fever, body aches, and upset stomach that occurred right after second shingrix vaccine with humira (adalimumab). On an unknown date, the patient's COVID 19 test was Negative. It was unknown if the reporter considered the generalized aching, fever and upset stomach to be related to Humira.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: SARS-CoV-2 test negative, Vaccination complication
Clinical narrative: pAIN; Fever; Upset stomach; This case was reported by a consumer via other manufacturer and described the occurrence of generalized aching in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for ulcerative colitis.   On an unknown date, the patient received the 2nd dose of Shingrix and Humira (subcutaneous) at an unknown dose and frequency. On an unknown date, immediately after receiving Shingrix, the patient experienced generalized aching, fever and upset stomach. The action taken with Humira was unknown. On an unknown date, the outcome of the generalized aching, fever and upset stomach were unknown.   It was unknown if the reporter considered the generalized aching, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient did not have any medical history. Concomitant drugs not reported. It was reported that the patient experienced vaccination adverse reaction fever, body aches, and upset stomach that occurred right after second shingrix vaccine with humira (adalimumab). On an unknown date, the patient's COVID 19 test was Negative. It was unknown if the reporter considered the generalized aching, fever and upset stomach to be related to Humira.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin irritation
Clinical narrative: Rash / on the left abdominal wall; On the left abdominal wall / some irritation; Herpes zoster; This case was reported by a nurse via and described the occurrence of rash in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 9H3Z4, expiry date 27th August 2022) for prophylaxis.   On 18th November 2020, the patient received Shingrix .5 ml. On 22nd November 2020, 4 days after receiving Shingrix, the patient experienced rash, skin irritation and herpes zoster. On an unknown date, the outcome of the rash, skin irritation and herpes zoster were unknown.   It was unknown if the reporter considered the rash, skin irritation and herpes zoster to be related to Shingrix.  Additional details were provided as follows: This case was reported by nurse. The patient received 1st dose and experienced  rash,abdominal wall with some irritation and herpes zoster. On 24th November the patient visited physician office and was diagnosed with Herpes zoster. The current outcome was unknown. The reporter consented to follow up. No further information was available.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased, Loss of consciousness
Clinical narrative: Passed out; Low heart rate; Possible pneumonia; A spontaneous report was received from a consumer concerning an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out, low heart rate, and possible pneumonia.    The patient's medical history was not reported. There were no concomitant medications provided.  On 15 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On 17 Jan 2021, the patient was hospitalized for passed out, low heart rate, and possible pneumonia. The reporter's mom found the patient passed out on the floor. It was thought he may have passed out about 4 or 5pm. The patient was taken to the emergency room (ER) via ambulance. At that time his heart rate was 20 bpm. Physicians said he may have pneumonia. It was noted the patient still works and walks miles every day. The patient was still hospitalized at the time of this report. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the events of passed out, low heart rate, and possible pneumonia was unknown at the time of this report.; Reporter's Comments: This case concerns a 84 year old male patient who experienced a serious unexpected events of passed out, low heart rate, and possible pneumonia.The event occurred 2 days 7 hours after first dose of the vaccine. Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the start date of the event/s, a causal relationship cannot be excluded.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Axillary pain, Cardiac arrest, Chest pain, Death
Clinical narrative: Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm, severe abdominal pain, muscle aches and cardiac arrest.    The patient's medical history was not provided Concomitant product use was not provided by the reporter.  On 14 Jan 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later, the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol.   Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died.   The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest, upper right chest pain and underneath the arm, severe abdominal pain, muscle aches.  The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine, in the absence of critical details such as the patient's medical history, any diagnostic test or autopsy result, adequate evaluation and assessment cannot be established. Main field defaults to possibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm, severe abdominal pain, muscle aches and cardiac arrest.    The patient's medical history was not provided Concomitant product use was not provided by the reporter.  On 14 Jan 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later, the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol.   Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died.   The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest, upper right chest pain and underneath the arm, severe abdominal pain, muscle aches.  The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine, in the absence of critical details such as the patient's medical history, any diagnostic test or autopsy result, adequate evaluation and assessment cannot be established. Main field defaults to possibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site extravasation
Clinical narrative: Felt like something dripping out of her; Felt like something dripping out of her; A spontaneous report was received from a consumer who was also a female patient, who received Moderna's COVID-19 Vaccine and experienced felt like something dripping out of her.  The patient's medical history was not provided. Concomitant product use was not provided.  On 18 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (batch number not reported) intramuscularly for COVID-19 infection prophylaxis.   The patient reported that when the nurse took the needle out, she then gently squeezed the site where the patient got the shot and the patient felt something dripping out of her. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The event, felt like something dripping out of her, was considered resolved on 18 Jan 2021.; Reporter's Comments: This case concerns a female patient who received the first of two planned doses of mRNA-1273 (batch number not reported) intramuscularly for COVID-19 infection prophylaxis and experienced felt like something dripping out of her. There were no reported adverse events after the vaccine was administered in this case of injection site extravasation and incomplete dose administered
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest discomfort, Eye swelling, Influenza, Nausea
Clinical narrative: pressure across chest; eyes were very swollen; flu symptoms; severe aches/  Pain radiated bilaterally up neck, mandibular area, trigeminal and into head; abdominal pain; nausea; Injection site very painful, could not touch; This is a spontaneous report from a contactable nurse reported for herself. This 62 Years old patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 12Jan2021 13:15 on Arm left at single dose (Lot # EL0142) for covid-19 immunisation. Medical history included hashimoto disease, allergies to maxide. Prior to vaccination, was the patient did not diagnose with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), valsartan, Pravastatin, docusate sodium (COLACE), wool fat (EUCERIN) and Vitamin D Nos. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 22Dec2020 13:15 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient woke up 13Jan2021 at 2:00 AM with flu symptoms - severe aches, abdominal pain and nausea. By 13Jan2021 4:30 eyes were very swollen. Slept 14 hours. Next night 14Jan2021 at 1AM, severe arm pain radiating across chest to other armpit - pressure across chest. Pain radiated bilaterally up neck, mandibular area, trigeminal and into head. Injection site very painful - could not touch in Jan2021. As the pain at injection site subsided - so did the symptoms. Events were non serious. No treatments were received. On 15Jan2021, laboratory details included nasal swab which showed negative. Outcome of the events was recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Smear test, Vaccination site pain
Clinical narrative: pressure across chest; eyes were very swollen; flu symptoms; severe aches/  Pain radiated bilaterally up neck, mandibular area, trigeminal and into head; abdominal pain; nausea; Injection site very painful, could not touch; This is a spontaneous report from a contactable nurse reported for herself. This 62 Years old patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 12Jan2021 13:15 on Arm left at single dose (Lot # EL0142) for covid-19 immunisation. Medical history included hashimoto disease, allergies to maxide. Prior to vaccination, was the patient did not diagnose with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), valsartan, Pravastatin, docusate sodium (COLACE), wool fat (EUCERIN) and Vitamin D Nos. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 22Dec2020 13:15 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient woke up 13Jan2021 at 2:00 AM with flu symptoms - severe aches, abdominal pain and nausea. By 13Jan2021 4:30 eyes were very swollen. Slept 14 hours. Next night 14Jan2021 at 1AM, severe arm pain radiating across chest to other armpit - pressure across chest. Pain radiated bilaterally up neck, mandibular area, trigeminal and into head. Injection site very painful - could not touch in Jan2021. As the pain at injection site subsided - so did the symptoms. Events were non serious. No treatments were received. On 15Jan2021, laboratory details included nasal swab which showed negative. Outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Feeling abnormal, Malaise
Clinical narrative: injection site pain; chills on and off yesterday; stomach hurting; feels cruddy and doesn't feel well / Feels cretty and does not feel well; feels cruddy and doesn't feel well / Feels cretty and does not feel well; nausea; diarrhea; This is a spontaneous report from a contactable other HCP (patient). A female patient of an unspecified age (age: 59; units: unknown) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3246), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she received the first dose of the Covid vaccine on Saturday (16Jan2021). Saturday night (16Jan2021) she experienced nausea and diarrhea, in which she was still experiencing diarrhea this morning. The patient also reported injection site pain, chills on and off yesterday (17Jan2021), and her stomach hurting. She stated that she felt cruddy and didn't feel well on 17Jan2021. The treatment reported as No. The outcome of event diarrhea was not resolved, outcome of other events was unknown.   Information on the Lot/Batch Number has been requested.  Follow-up (18Jan2021): New information received from a contactable other HCP included: patient weight and height, lot number of vaccine, no treatment.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: injection site pain; chills on and off yesterday; stomach hurting; feels cruddy and doesn't feel well / Feels cretty and does not feel well; feels cruddy and doesn't feel well / Feels cretty and does not feel well; nausea; diarrhea; This is a spontaneous report from a contactable other HCP (patient). A female patient of an unspecified age (age: 59; units: unknown) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3246), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she received the first dose of the Covid vaccine on Saturday (16Jan2021). Saturday night (16Jan2021) she experienced nausea and diarrhea, in which she was still experiencing diarrhea this morning. The patient also reported injection site pain, chills on and off yesterday (17Jan2021), and her stomach hurting. She stated that she felt cruddy and didn't feel well on 17Jan2021. The treatment reported as No. The outcome of event diarrhea was not resolved, outcome of other events was unknown.   Information on the Lot/Batch Number has been requested.  Follow-up (18Jan2021): New information received from a contactable other HCP included: patient weight and height, lot number of vaccine, no treatment.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash; right inguinal large tender lymphadenopathy appeared same time; fatigue; muscle aches; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) via an unspecified route of administration on 12Jan2021 14:00 at single dose in left arm for COVID19 immunisation. Patient age at time of vaccination was 56 Years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) administered on 22Dec2020 at 14:00 in left arm. The patient has allergies to Duricef, milk, almonds. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received unspecified concomitant medications. On 13Jan2021 the patient experienced Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash appeared 18 hours after 2nd Covid vaccine; right inguinal large tender lymphadenopathy appeared same time; also had normal fatigue, muscle aches from vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. As treatment for the events the patient received Acyclovir 800 mg QID x 7 days and terrasil ointment. The events were reported as non serious. Since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash; right inguinal large tender lymphadenopathy appeared same time; fatigue; muscle aches; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) via an unspecified route of administration on 12Jan2021 14:00 at single dose in left arm for COVID19 immunisation. Patient age at time of vaccination was 56 Years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) administered on 22Dec2020 at 14:00 in left arm. The patient has allergies to Duricef, milk, almonds. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received unspecified concomitant medications. On 13Jan2021 the patient experienced Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash appeared 18 hours after 2nd Covid vaccine; right inguinal large tender lymphadenopathy appeared same time; also had normal fatigue, muscle aches from vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. As treatment for the events the patient received Acyclovir 800 mg QID x 7 days and terrasil ointment. The events were reported as non serious. Since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.