chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Malaise, Nausea, Somnolence
Clinical narrative: passed out; not feeling well; dizziness; could not get up; slept all day on and off; bruised knees; washed in cold sweat; nausea; fatigue; vomiting; bad headache; tender arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL for Blood pressure.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (tender arm). On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting) and HEADACHE (bad headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting), VACCINATION SITE PAIN (tender arm) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not receive any treatment for the events.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: passed out; not feeling well; dizziness; could not get up; slept all day on and off; bruised knees; washed in cold sweat; nausea; fatigue; vomiting; bad headache; tender arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL for Blood pressure.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (tender arm). On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting) and HEADACHE (bad headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting), VACCINATION SITE PAIN (tender arm) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not receive any treatment for the events.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia, Rectal haemorrhage
Clinical narrative: some blood while  wiped down; blood stained stools; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (some blood while  wiped down) and HAEMATOCHEZIA (blood stained stools) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced RECTAL HAEMORRHAGE (some blood while  wiped down) (seriousness criterion medically significant) and HAEMATOCHEZIA (blood stained stools) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (some blood while  wiped down) and HAEMATOCHEZIA (blood stained stools) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 01-Apr-2021,the patient underwent a scan study using dye called Coronary-CTA.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. I would consider a query asking the reporter to clarify the indication for the CTA study.  It is strange that this study was done 1 day before second dose and preceding the events.  We could be missing another SAE, or this could have been planned prior to vaccine dosing.  We just don't know.  If the patient has coronary issues that preceded the second dose perhaps they were placed on blood thinners that could have contributed to the rectal bleeding.   This case was linked to MOD21-069281 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. I would consider a query asking the reporter to clarify the indication for the CTA study.  It is strange that this study was done 1 day before second dose and preceding the events.  We could be missing another SAE, or this could have been planned prior to vaccine dosing.  We just don't know.  If the patient has coronary issues that preceded the second dose perhaps they were placed on blood thinners that could have contributed to the rectal bleeding. MOD21-069281:MOD-2021-067512 -1st dose of Vaccine
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Thrombosis
Clinical narrative: Blood clot on her eye after vaccination; Her HCP told her that she could wait even 3 months to get the 2nd dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot on her eye after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Enucleation of eyeball.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot on her eye after vaccination) (seriousness criterion hospitalization) and OFF LABEL USE (Her HCP told her that she could wait even 3 months to get the 2nd dose). At the time of the report, THROMBOSIS (Blood clot on her eye after vaccination) and OFF LABEL USE (Her HCP told her that she could wait even 3 months to get the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown. Treatment information not provided. Her HCP told her that she could wait even 3 months to get the 2nd dose Patient decided not to give more information as she believed it wouldn´t help her.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot in leg) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039KZ014) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced THROMBOSIS (Blood clot in leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in leg) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Syncope
Clinical narrative: patient collapsed and taken to emergency department; low blood pressure; becoming depressed; difficulty sleeping due to rash; felt itchy on the inside of the body; rash that covered his arms, upper torso, shoulders and went down the back/rash developing on face and neck; nausea; dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (patient collapsed and taken to emergency department) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided.).    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On 31-Mar-2021, the patient experienced DEPRESSION (becoming depressed), INSOMNIA (difficulty sleeping due to rash), PRURITUS (felt itchy on the inside of the body) and RASH (rash that covered his arms, upper torso, shoulders and went down the back/rash developing on face and neck). On 01-Apr-2021, the patient experienced SYNCOPE (patient collapsed and taken to emergency department) (seriousness criterion medically significant) and HYPOTENSION (low blood pressure). At the time of the report, SYNCOPE (patient collapsed and taken to emergency department), HYPOTENSION (low blood pressure), DEPRESSION (becoming depressed), DIZZINESS (dizziness), INSOMNIA (difficulty sleeping due to rash), PRURITUS (felt itchy on the inside of the body), RASH (rash that covered his arms, upper torso, shoulders and went down the back/rash developing on face and neck) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   A pharmacist suggested the patient take Children's Benadryl followed by Zyrtec to help with the itching. These medicines have not helped alleviate his intense itching. On 1Apr2021, the patient collapsed and was taken to the emergency department. The patient was treated at the emergency department after he collapsed from low blood pressure. He was prescribed Hydroxyzine HCI 10mg for the itching by the emergency room physician, but the medicine has done nothing to alleviate the patient's symptoms.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events of vaccination site reaction, a causal relationship cannot be excluded. Ras and nausea are consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events of vaccination site reaction, a causal relationship cannot be excluded. Ras and nausea are consistent with the known safety profile of the vaccine.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Product dose omission issue
Clinical narrative: pneumonia, illness; missed her 2nd appointment; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia, illness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia, illness) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd appointment). At the time of the report, PNEUMONIA (pneumonia, illness) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd appointment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant meds: H. blood pressure medicines.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Injection site reaction
Clinical narrative: Dyskinesia of the tongue, left face, Jaw, and Lips; Delayed Reaction; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DYSKINESIA (Dyskinesia of the tongue, left face, Jaw, and Lips) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ehlers-Danlos syndrome, Mast cell activation syndrome, Postural orthostatic tachycardia syndrome, Erythromelalgia, Cystitis interstitial, Delayed gastric emptying, Acid reflux (esophageal), Osteopenia, Occipital neuralgia and Neuralgia. Concomitant products included PENTOSAN POLYSULFATE SODIUM (ELMIRON), PROPRANOLOL, DEXLANSOPRAZOLE (DEXILANT), FAMOTIDINE, ETHINYLESTRADIOL, LEVONORGESTREL (CAMRESE) and ALPRAZOLAM (XANAX) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DYSKINESIA (Dyskinesia of the tongue, left face, Jaw, and Lips) (seriousness criterion hospitalization) and INJECTION SITE REACTION (Delayed Reaction). On 06-Feb-2021, DYSKINESIA (Dyskinesia of the tongue, left face, Jaw, and Lips) and INJECTION SITE REACTION (Delayed Reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medication included Hizentai for unknown indication.  Treatments: Aleve, Advil, Tylenol, Cromolyn Sodium 100mg/5ml orally daily, and applying Cromolyn Sodium to face topically, Naltrexone 4.5mg, Zirbel , Myrbetriq 60mg daily, Ondansetron 8mg PRN Nausea, Hydroxyzine 25mg, Hemax , Hyoscyamine 0.1 Oral PRN.     This case was linked to MOD-2021-036762 (Patient Link).; Sender's Comments: This case concerns a 39-year-old female with a serious unexpected event of dyskinesia and expected injection site reaction. Event onset 16 days after first dose. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: when he went to take the cotton ball off there was a 3/4" in by 3/8" of diluted blood; This is a spontaneous report from a contactable consumer via Medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown, Expiration date; unknown), via an unspecified route of administration on 20Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine yesterday and last night on 20Jan2021, when he went to take the cotton ball off, there was a 3/4" in by 3/8" of diluted blood. The consumer stated, "We are worried the medicine just come right back out." The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19 Mar 2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Blood pressure measurement, Chills, Fatigue
Clinical narrative: Flu-ish/ Feel flu like a couple of days ago/ I thought I was coming down with flu; Sharp pain in his stomach/ stomach hurt very bad/ stomach felt like it's going to come out of me/ really bad for about 5 or 6 hours; nausea; muscle pain; headache; Joint pain; fatigue; chills; Cold; Sick; I don't feel well/ Hasn't been feeling good; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3240, Expiration Date: Unknown), via an unspecified route of administration on 19Jan2021 at 11:00 (at the age of 71 years-of-old) as a single dose for COVID-19 vaccination. Relevant medical history included hypertension. Concomitant medication included Enalapril maleate (ANAPRIL) (MANUFACTURER UNKNOWN) for High blood pressure from an unknown date and unknown if ongoing.  On an unspecified date, the patient experienced "Flu-ish" a couple of days ago with sharp pains in his stomach, nausea, muscle pain, headache, fatigue, and chills, cold. Thought he was coming down with flu. Nausea. Sick; dint feel well. Hasn't been feeling good. Reporter stated, yesterday he had a really bad day. He got the shot about week ago and all day long hurt really badly, his stomach. Reported stated he did not have diarrhea or not like that. Had chills, joint pain, nausea so, was that kind of normal after a week was the query. Reported stated really bad for about 5 or 6 hours, really bad, stomach felt like it's going to come out. No investigational assessment, lab test in the past two weeks. The outcome of all the events was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Illness, Influenza like illness, Myalgia
Clinical narrative: Flu-ish/ Feel flu like a couple of days ago/ I thought I was coming down with flu; Sharp pain in his stomach/ stomach hurt very bad/ stomach felt like it's going to come out of me/ really bad for about 5 or 6 hours; nausea; muscle pain; headache; Joint pain; fatigue; chills; Cold; Sick; I don't feel well/ Hasn't been feeling good; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3240, Expiration Date: Unknown), via an unspecified route of administration on 19Jan2021 at 11:00 (at the age of 71 years-of-old) as a single dose for COVID-19 vaccination. Relevant medical history included hypertension. Concomitant medication included Enalapril maleate (ANAPRIL) (MANUFACTURER UNKNOWN) for High blood pressure from an unknown date and unknown if ongoing.  On an unspecified date, the patient experienced "Flu-ish" a couple of days ago with sharp pains in his stomach, nausea, muscle pain, headache, fatigue, and chills, cold. Thought he was coming down with flu. Nausea. Sick; dint feel well. Hasn't been feeling good. Reporter stated, yesterday he had a really bad day. He got the shot about week ago and all day long hurt really badly, his stomach. Reported stated he did not have diarrhea or not like that. Had chills, joint pain, nausea so, was that kind of normal after a week was the query. Reported stated really bad for about 5 or 6 hours, really bad, stomach felt like it's going to come out. No investigational assessment, lab test in the past two weeks. The outcome of all the events was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Flu-ish/ Feel flu like a couple of days ago/ I thought I was coming down with flu; Sharp pain in his stomach/ stomach hurt very bad/ stomach felt like it's going to come out of me/ really bad for about 5 or 6 hours; nausea; muscle pain; headache; Joint pain; fatigue; chills; Cold; Sick; I don't feel well/ Hasn't been feeling good; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3240, Expiration Date: Unknown), via an unspecified route of administration on 19Jan2021 at 11:00 (at the age of 71 years-of-old) as a single dose for COVID-19 vaccination. Relevant medical history included hypertension. Concomitant medication included Enalapril maleate (ANAPRIL) (MANUFACTURER UNKNOWN) for High blood pressure from an unknown date and unknown if ongoing.  On an unspecified date, the patient experienced "Flu-ish" a couple of days ago with sharp pains in his stomach, nausea, muscle pain, headache, fatigue, and chills, cold. Thought he was coming down with flu. Nausea. Sick; dint feel well. Hasn't been feeling good. Reporter stated, yesterday he had a really bad day. He got the shot about week ago and all day long hurt really badly, his stomach. Reported stated he did not have diarrhea or not like that. Had chills, joint pain, nausea so, was that kind of normal after a week was the query. Reported stated really bad for about 5 or 6 hours, really bad, stomach felt like it's going to come out. No investigational assessment, lab test in the past two weeks. The outcome of all the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pruritus
Clinical narrative: Nausea; Very low-grade pain in ankles , wrists, knuckles; slight headache; tiredness; itching in lower arms & legs; This is a spontaneous report received from a contactable consumer (patient) herself. A 74-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, lot Number: EL3246) via an unspecified route of administration, on left arm on 25Jan2021 17:00 at single dose for covid-19 immunisation. Medical history included asthma, dermatitis, osteoporosis, psoriasis, bradycardia, allergies to molds, grasses, tress, glowers primarily and other allergens. Concomitant medications included theophylline, salbutamol (ALBUTEROL), fluticasone propionate (FLOVENT) and lisinopril. Since the vaccination, the patient had not tested positive for COVID-19. Patient has not had symptoms associated with COVID-19. On 26Jan2021 02:30, the patient experienced nausea, very low-grade pain in ankles, wrists, knuckles, slight headache, tiredness and itching in lower arms and legs (the latter still ongoing 40+ hours later). The outcome of the events were recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Arm became sore to the touch at site of injection and in the muscle at my shoulder/bicep muscle at the site of injection; Arm became sore to the touch at site of injection and in the muscle at my shoulder/bicep muscle at the site of injection; had pain if the site was barely touched and also in lifting my arm; This is a spontaneous report from a contactable consumer (patient).  This 36-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3248), via an unspecified route of administration in the right arm, on 28Jan2021 at 07:30 (at the age of 36-year-old) at single dose for COVID-19 immunisation, administered at . Relevant medical history included allergy to NSAIDS. Relevant concomitant medications bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC) and probiotics. No other vaccine was received in four weeks. On 28Jan2021 (at 10:00), her arm became sore to the touch at site of injection and in the muscle at her shoulder/bicep muscle at the site of injection and just below on her bicep. During the evening and overnight she had pain if the site was barely touched and also in lifting her arm during housework. Today, (day after vaccine), the injection site was still sore to the touch but she have more mobility in her shoulder/bicep. Nothing unbearable and she still look forward to the second dose. The patient was not treated for the events.  Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report received report from a Pfizer sponsored program Pfizer First Connect. A 64-Year-Old male consumer reported that he received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection) via unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. On an unspecified date, patient experienced body pain. Therapeutic measures were taken which included Steroids and Tylenol prescribed from her family physician. The outcome of the event was unknown.  Follow up (29Jan2021): The initial case was missing the following minimum criteria: This case has been considered invalid as Other-info not qualifying for AE reporting- Medical Information. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid. He received the 1st shot of our vaccine last 27Jan2021 and his doctor prescribed him to take Steroids and Tylenol for his body pain.  Information on Lot/Batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Pain
Clinical narrative: woke up and had lost voice (very hoarse) for a week after; Body aches night of vaccine; This is a spontaneous report from a contactable other hcp reported for herself. A 41-years-old female patient received First dose of BNT162B2 (Pfizer-Biontech Covid-19 Mrna Vaccine, Formulation: Solution for injection) via an unspecified route of administration, in right arm on 12Jan2021 at 10:00 (Batch/Lot Number: Eh9899) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); dexamethasone (ZINE [DEXAMETHASONE]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Patient was not allergic to medications, food, or other products. On 12Jan2021 at 03:00, The patient experienced body aches night Went away next morning of vaccine and but woke up and had lost voice (very hoarse) for a week after. No treatment was received for the adverse event. On 13Jan2021, the outcome of the event pain was resolved and on an unspecified date the event Hoarseness of voice was resolved.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Increased appetite, Taste disorder
Clinical narrative: voracious appetite,  about 24 hours after 2nd dose; voracious appetite,  about 24 hours after 2nd dose, all food tasted bland; This is a spontaneous report from a contactable consumer (patient itself).  A 76-years-old non-pregnant female patient received second dose of BNT162B2(Solution for injection, Lot Number: EL3248 and Expiration date was unknown),  via an unspecified route of administration, administered in Arm Left on 01Feb2021 13:00 as SINGLE DOSE for covid-19 immunization .Historical vaccine included first dose of BNT162B2(Solution for injection, Lot Number: EL0142and Expiration date was unknown),  via an unspecified route of administration, administered in Arm Left on 11Jan2021 16:30 as SINGLE DOSE for covid-19 immunization.  The patient medical history was not reported. Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) 40 mg, daily taken for an unspecified indication, start and stop date were not reported. On 01Feb2021, the patient experienced voracious appetite,  about 24 hours after the 2nd dose  , all food tasted bland. Seriousness of the events reported as non-serious. The patient had not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: 4 days low grade Nausea; Sore (L) Arm x24 hours; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247, Expiry date: 14Jan2021) on 14Jan2021, 14:30 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231, Expiry date: 23Dec2020) on 23Dec2020, 14:30 both via intramuscular route of administration in left arm as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore in left arm x24 hours on 14Jan2021 21:00 and 4 days low grade nausea on an un-specified date. The reporter assessed the events as non-serious. The outcome of the event was unknown.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: feeling tired; feel a little "whoo"; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Jan2021 08:00 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other vaccine on the same day of COVID-19 vaccine. On 22Jan2021, after vaccination patient experienced feeling tired and feel a little whoo. The events were considered as non-serious. The outcome of the events was recovering.   information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye pruritus, Fatigue, Hypersomnia, Malaise
Clinical narrative: slept over 20 hours day 4, plus 12 day 5; Joint and muscle pain; Joint and muscle pain; extreme fatigue/exhausted; Congested with runny nose; Congested with runny nose; itchy eyes; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) intramuscular, administered in Arm Left on 29Jan2021 09:45 am (at the age of 40-years-old) at a single dose for covid-19 immunisation. Medical history included sinus tachycardia, panic disorder, depression, chronic fatigue syndrome, PCOS. Allergies to medications, food, or other products was Penicillin. Concomitant medication patient received within 2 weeks of vaccination included Metformin 500mg, Metoprolol 50 mg, Paroxetine 50 mg and vitamin D. The patient previously took first dose of BNT162B2 (lot number: EL0140) on 08Jan2021 on right arm at a single dose for covid-19 immunisation and 2 weeks or so after first shot, noticed severe itching on my left upper thigh with bumps and after this shot, itching has spread to face and arms. The patient experienced joint and muscle pain, extreme fatigue/exhausted on 31Jan2021, slept over 20 hours day 4, plus 12 day 5 on 01Feb2021 and congested with runny nose, itchy eyes, generally feeling ill in 2021. The event was considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Oropharyngeal: negative on 01Feb2021. The outcome of all the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: slept over 20 hours day 4, plus 12 day 5; Joint and muscle pain; Joint and muscle pain; extreme fatigue/exhausted; Congested with runny nose; Congested with runny nose; itchy eyes; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) intramuscular, administered in Arm Left on 29Jan2021 09:45 am (at the age of 40-years-old) at a single dose for covid-19 immunisation. Medical history included sinus tachycardia, panic disorder, depression, chronic fatigue syndrome, PCOS. Allergies to medications, food, or other products was Penicillin. Concomitant medication patient received within 2 weeks of vaccination included Metformin 500mg, Metoprolol 50 mg, Paroxetine 50 mg and vitamin D. The patient previously took first dose of BNT162B2 (lot number: EL0140) on 08Jan2021 on right arm at a single dose for covid-19 immunisation and 2 weeks or so after first shot, noticed severe itching on my left upper thigh with bumps and after this shot, itching has spread to face and arms. The patient experienced joint and muscle pain, extreme fatigue/exhausted on 31Jan2021, slept over 20 hours day 4, plus 12 day 5 on 01Feb2021 and congested with runny nose, itchy eyes, generally feeling ill in 2021. The event was considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Oropharyngeal: negative on 01Feb2021. The outcome of all the events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest discomfort, Cough, Fatigue, Nasopharyngitis
Clinical narrative: cough; tight chest; large amount of post-nasal drainage; sinus congestion; extreme fatigue; slightly elevated temp; feeling like I was developing a cold; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 12:45 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic sinusitis, chronic venous insufficiency. Allergies to medications, food, or other products: Ibuprofen (sensitive). Concomitant medication(s) included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported; medroxyprogesterone (MEDROXYPROGESTERONE) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient received these medications including multivita within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Since 04Feb2021 05:45am, morning following vaccine administration, the patient had a cough, tight chest, large amount of post-nasal drainage, sinus congestion, extreme fatigue, slightly elevated temp - feeling like she was developing a cold. She had previously been diagnosed with and treated for chronic sinusitis. No treatment received for the adverse event. The events were assessed as non-serious. Outcome of the events was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinus congestion
Clinical narrative: cough; tight chest; large amount of post-nasal drainage; sinus congestion; extreme fatigue; slightly elevated temp; feeling like I was developing a cold; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 12:45 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic sinusitis, chronic venous insufficiency. Allergies to medications, food, or other products: Ibuprofen (sensitive). Concomitant medication(s) included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported; medroxyprogesterone (MEDROXYPROGESTERONE) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient received these medications including multivita within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Since 04Feb2021 05:45am, morning following vaccine administration, the patient had a cough, tight chest, large amount of post-nasal drainage, sinus congestion, extreme fatigue, slightly elevated temp - feeling like she was developing a cold. She had previously been diagnosed with and treated for chronic sinusitis. No treatment received for the adverse event. The events were assessed as non-serious. Outcome of the events was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Chills, Nausea, Headache, Body Ache, Skin Hurt, Left hand pain base of middle finger back of hand Lasted about 5 hours, Headache remained into the next morning. Took Benadryl and Ibuprofen
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: Chills, Nausea, Headache, Body Ache, Skin Hurt, Left hand pain base of middle finger back of hand Lasted about 5 hours, Headache remained into the next morning. Took Benadryl and Ibuprofen
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Pt states difficulty breathing. Upon interview by provider it was determined the reaction may be due to anxiety
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Additional Details: Patient started feeling dizzy within 5 minutes after vaccine administration. Patient vomitted once during observation period. Patient also stated feeling ringing in ears and vision darkening right before throwing up. Patient felt better after throwing up. Patient was observed for total 30 minutes.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Visual impairment, Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Additional Details: Patient started feeling dizzy within 5 minutes after vaccine administration. Patient vomitted once during observation period. Patient also stated feeling ringing in ears and vision darkening right before throwing up. Patient felt better after throwing up. Patient was observed for total 30 minutes.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Male consumer received Pfizer's COVID vaccine on 18Jan2021 and caught COVID 19 a week ago; This is a spontaneous report from a contactable consumer (himself). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 18Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: negative in 2021.  Male consumer received pfizer's covid vaccine on 18Jan2021 and caught covid 19 a week ago on Jan2021. The outcome of the event was recovered on an unspecified date 2021.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pins and needles in both feet, slight numbness
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Confusional state, Cough
Clinical narrative: Shortness of breath, difficulty breathing, difficulty speaking, chills, violent shaking, left kidney pain , headache, Coughing body aches, fatigue, confusion, difficulty sleeping ,loss of appetite, weakness , burning in my lungs
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Headache, Insomnia
Clinical narrative: Shortness of breath, difficulty breathing, difficulty speaking, chills, violent shaking, left kidney pain , headache, Coughing body aches, fatigue, confusion, difficulty sleeping ,loss of appetite, weakness , burning in my lungs
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Renal pain, Tremor
Clinical narrative: Shortness of breath, difficulty breathing, difficulty speaking, chills, violent shaking, left kidney pain , headache, Coughing body aches, fatigue, confusion, difficulty sleeping ,loss of appetite, weakness , burning in my lungs
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient stated she felt ringing in the ear and darkening of vision within 5 minutes of vaccine administration. Patient felt better after drinking orange juice, and water. Patient was observed for total 30 minutes.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Injection site pain, Pain, Phantom limb syndrome
Clinical narrative: Body aches, headache, weakness in the receiving arm and hand, feels like the injection site is on fire (very painful 7 on the pain scale), my phantom pain is going nuts in my missing left forearm and hand (very painful too 7 on the pain scale)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Neuralgia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: neuralgia of the left extremity-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Headache and arm soreness first day.  neck issues day 2. very stiff and sore.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Fatigue, Headache
Clinical narrative: Temp of 100.4 off and on for 24 hours; Sore arm; Slight redness; Chills; Headache; Tiredness - slept for 20 out of 24 hours post injection; This is a spontaneous report from a contactable Other HCP (patient). A 51-year-old (non-pregnant) female patient received BNT162B2 (Solution for injection, Lot number: EL9265) via unknown route of administration on 03Feb2021 at 10.45 AM first dose at right arm, single dose for COVID-19 immunisation. The patient's medical history included Covid (prior to vaccination). The concomitant medications were not reported. On 03Feb2021 at 09:00 PM, patient experienced sore arm, slight redness, chills, headache, tiredness (slept for 20 out of 24 hours post injection) and temperature of 100.4 off and on for 24 hours. The patient did not receive any treatment for the events. The outcome of the events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Temp of 100.4 off and on for 24 hours; Sore arm; Slight redness; Chills; Headache; Tiredness - slept for 20 out of 24 hours post injection; This is a spontaneous report from a contactable Other HCP (patient). A 51-year-old (non-pregnant) female patient received BNT162B2 (Solution for injection, Lot number: EL9265) via unknown route of administration on 03Feb2021 at 10.45 AM first dose at right arm, single dose for COVID-19 immunisation. The patient's medical history included Covid (prior to vaccination). The concomitant medications were not reported. On 03Feb2021 at 09:00 PM, patient experienced sore arm, slight redness, chills, headache, tiredness (slept for 20 out of 24 hours post injection) and temperature of 100.4 off and on for 24 hours. The patient did not receive any treatment for the events. The outcome of the events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Nausea Dizzy  Fever Pain at injection site Headache
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy placenta, Chills, Foetal death, Haematocrit, Haemoglobin
Clinical narrative: Within 6 hours of admin all over body aches, chills, malaise. Fetus was 13w6d at time of mother?s administration, fetal death estimated early 14 w.  Mother induced to abort at 15w by cytotec induction; Hospitalization followed to monitor bleeding.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: Within 6 hours of admin all over body aches, chills, malaise. Fetus was 13w6d at time of mother?s administration, fetal death estimated early 14 w.  Mother induced to abort at 15w by cytotec induction; Hospitalization followed to monitor bleeding.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Moderate headache, pronounced fatigue, slight fever, medium body aches