chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Allergic Reaction; Tongue and throat swelled; Tongue and throat swelled; Feeling odd; Shortness of breath/not breathing as normal; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Allergic Reaction), SWOLLEN TONGUE (Tongue and throat swelled) and PHARYNGEAL SWELLING (Tongue and throat swelled) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B04021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history was reported by reporter.  Concomitant products included THIAMINE (VITAMIN B1 [THIAMINE]) for an unknown indication.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, the patient experienced HYPERSENSITIVITY (Allergic Reaction) (seriousness criterion hospitalization), SWOLLEN TONGUE (Tongue and throat swelled) (seriousness criterion hospitalization) and PHARYNGEAL SWELLING (Tongue and throat swelled) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling odd) and DYSPNOEA (Shortness of breath/not breathing as normal). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic Reaction), SWOLLEN TONGUE (Tongue and throat swelled), PHARYNGEAL SWELLING (Tongue and throat swelled) and FEELING ABNORMAL (Feeling odd) outcome was unknown and DYSPNOEA (Shortness of breath/not breathing as normal) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2021, Blood pressure measurement: 147 (High) Blood pressure 147 high.     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 was suffered with Shortness of breath ,  feeling better. patient  doesn't have a main doctor but provides information of the hospital and Doctor that treat his allergic reaction after taking the vaccine, gives consent to safety follow up.  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: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Product administered to patient of inappropriate age
Clinical narrative: Died three days after vaccine; 13 year old boy dies three days after the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died three days after vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old boy dies three days after the Moderna vaccine). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old boy dies three days after the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was unknown.  Company comment: This is a case of death in a 13-year-old male subject with unknown medical history, who died one day after receiving the vaccine. Very limited information has been provided at this time. Further information has been requested.; Sender's Comments: This is a case of death in a 13-year-old male subject with unknown medical history, who died one day after receiving the vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clots in Lung; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood Clots in Lung) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced THROMBOSIS (Blood Clots in Lung) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (a quarter of lungs removed) for Thrombosis. At the time of the report, THROMBOSIS (Blood Clots in Lung) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product were not provided.  Treatment medication were not reported.  The patient was in stable condition since he released from the hospital.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diverticulum, Fatigue, Infection, Pulmonary embolism
Clinical narrative: Infection; Diverticulosis episodes; Shivers; Shattering; 2 small blood clots one in each lung; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (2 small blood clots one in each lung), INFECTION (Infection), DIVERTICULUM (Diverticulosis episodes), CHILLS (Shivers) and FATIGUE (Shattering) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced PULMONARY EMBOLISM (2 small blood clots one in each lung) (seriousness criteria hospitalization and medically significant), DIVERTICULUM (Diverticulosis episodes) (seriousness criterion hospitalization), CHILLS (Shivers) (seriousness criterion hospitalization) and FATIGUE (Shattering) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (2 small blood clots one in each lung), INFECTION (Infection), DIVERTICULUM (Diverticulosis episodes), CHILLS (Shivers) and FATIGUE (Shattering) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information included high blood pressure medication (unspecified).  At the time of report, the patient was at the hospital.  Treatment information included medication for blood clots (unspecified).  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.; 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: Vertigo
Clinical narrative: hospitalized for 3 days and was sick for about a month because of vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (hospitalized for 3 days and was sick for about a month because of vertigo) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (hospitalized for 3 days and was sick for about a month because of vertigo) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to VERTIGO. At the time of the report, VERTIGO (hospitalized for 3 days and was sick for about a month because of vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information provided.  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.; 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.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Gout, Laboratory test
Clinical narrative: joint pain and subsequent diagnosis of gout/arthritis
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Fatigue, Feeling abnormal
Clinical narrative: She began feeling badly the day after 2nd dose.  Sore throat, runny nose, sneezing, headache, fatigue. Today is 4th day after 2nd dose and  she feels pretty awful. Started running low fever and complaining of *chest pain* and *pain in back and shoulders* and pain upon *deep breaths*.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pleurisy, Pyrexia, Rhinorrhoea
Clinical narrative: She began feeling badly the day after 2nd dose.  Sore throat, runny nose, sneezing, headache, fatigue. Today is 4th day after 2nd dose and  she feels pretty awful. Started running low fever and complaining of *chest pain* and *pain in back and shoulders* and pain upon *deep breaths*.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: She began feeling badly the day after 2nd dose.  Sore throat, runny nose, sneezing, headache, fatigue. Today is 4th day after 2nd dose and  she feels pretty awful. Started running low fever and complaining of *chest pain* and *pain in back and shoulders* and pain upon *deep breaths*.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: My arm has been hurting since my second dose of Moderna.  From injection site up to the tip of my shoulder blade.  It burns & stings, especially with certain range of motions.  It is very uncomfortable, it has been 4 months!!!
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Angiogram, Anticoagulant therapy, Aphasia, Cerebral venous sinus thrombosis
Clinical narrative: On the night of 4/26 I experienced the worst headache of my life and severe GI upset. The GI upset abated within 24 hours but the headaches persisted on and off for over a month until the night of 6/10, when, after sleeping for 25 hours, I was unable to talk. My partner took me to the ER where it was determined I was having a stroke. I was transferred to another hospital, where I was diagnosed with CVST/Thalamic Stroke and a thrombectomy was performed, followed by an angiogram later that week. As a result of my hypercoagulated state and the angiogram, I developed another clot in my right arm. I was on Heparin and then Coumadin, with Lovenox as a bridge. I just got out of rehab this week.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache, Hypersomnia, Thrombectomy, Thrombosis
Clinical narrative: On the night of 4/26 I experienced the worst headache of my life and severe GI upset. The GI upset abated within 24 hours but the headaches persisted on and off for over a month until the night of 6/10, when, after sleeping for 25 hours, I was unable to talk. My partner took me to the ER where it was determined I was having a stroke. I was transferred to another hospital, where I was diagnosed with CVST/Thalamic Stroke and a thrombectomy was performed, followed by an angiogram later that week. As a result of my hypercoagulated state and the angiogram, I developed another clot in my right arm. I was on Heparin and then Coumadin, with Lovenox as a bridge. I just got out of rehab this week.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Artery dissection, Myocardial infarction
Clinical narrative: Had a heart attack due to a tear in artery.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over my body started 2 days after my second dose of the covid vaccination. There are no rashes and no itching at the injection sight, but my entire body has been itching since Friday June 25th 2021 and still itches today on July 11th 2021.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Developed sore throat after 8 days of getting first vaccine shot.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Laboratory test abnormal, Lymphadenopathy, Mass
Clinical narrative: Severe arm and shoulder pain has not subsided now two months after the injection. My shoulder and neck hurt when I lift my arm. I have limited range of motion in my left arm since the vaccine. I also have a supraclavicular lump on my left side that appeared 5 days after the shot.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Vaccination complication, X-ray abnormal
Clinical narrative: Severe arm and shoulder pain has not subsided now two months after the injection. My shoulder and neck hurt when I lift my arm. I have limited range of motion in my left arm since the vaccine. I also have a supraclavicular lump on my left side that appeared 5 days after the shot.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: started with chills, slight fever, went away after about 3 days, and then a hoarse cough like he needs to clear his throat, currently been 7 days and teen continues to cough about 15 times per day. Is this normal? doesnt seem to bother him much? Is this something to worry about?
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Dermatographia, migrating hives
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Hysteroscopy normal, Menstruation irregular, Oligomenorrhoea, Ultrasound scan normal
Clinical narrative: Irregular menstrual bleeding (duration 2.5+ months, normal Hysteroscopy and ultrasound). Currently taking oral contraceptives to try to correct.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chest X-ray normal, Chest discomfort, Chest pain, Cough
Clinical narrative: Heavy chest/heart pain and tightness for around 12 hours. Lungs were burning and had a cough for around 12 hours as well. Slight nausea for around 1 hour.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Nausea
Clinical narrative: Heavy chest/heart pain and tightness for around 12 hours. Lungs were burning and had a cough for around 12 hours as well. Slight nausea for around 1 hour.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil count increased, Fatigue, Full blood count abnormal, Petechiae, Rash
Clinical narrative: I am by no means a doctor, but I wanted to report this for any benefit it may provide. Three days after vaccine I got a bunch of tiny dots all over my torso, upper portion of legs and a few on my arms. They are tiny pin point sized red dots that are flat and do not change color when I press on them. To the best of my knowledge, they look like Petechiae. I have never had dots like this before. I felt fine other than a little fatigue and the rash.  Not wanting to have to rush to a medical facility and spend a long duration of time indoors due to Covid-19 fears, I self ordered labs from an outside laboratory to see if my platelets were ok. I have had two CBC tests done so far.  Luckily, so far, they have looked normal. Now it is over 2 weeks after the first shot and I still have these tiny dots on my skin. I am hoping they go away on their own and I can get the second shot.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable Consumer.   An unspecified age male Consumer (Age: 68; Unit: Unknown) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine on 29Jan2021. The patient stated that he was reading the Fact Sheet, in which he wanted to verify the information that was on the Fact Sheet. Caller asked how long after the second dose will 95% efficacy occur. The patient stated that he had efficacy reports from Pfizer that read if you experience tiredness, the vaccine is working. The patient reported experiencing tiredness after the vaccine on an unspecified date. He read on the fact sheet about the benefits of the vaccine. The information showed it prevents the virus following two doses plus seven days. Then you are good after getting the vaccine doses three weeks apart. The patient wanted to know was there any additional information that goes with it. He did not believe some of the idiots on the news. "Some people think it is 65% effective, but they don't explain it". No other details were provided. The patient was curious that how long after the second dose you were fully protected. His next dose was due scheduled for 19Feb2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: torso started to itch and she wasn't sure if it looked like a heat rash or it just got irritated/the back of her neck and her shoulders also started to itch and they were red; torso started to itch and she wasn't sure if it looked like a heat rash or it just got irritated/the back of her neck and her shoulders also started to itch and they were red; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 08Feb2021 16:15 (33-Years-old at the time of vaccination), (Lot Number: LN6201, Expiry date: Unknown) as dose 1, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient stated that she had the first dose of the Pfizer COVID-19 vaccine yesterday (08Feb2021) at 4:15PM. On 08Feb2021, at 10:30 PM, her torso started to itch, and she wasn't sure if it looked like a heat rash or it just got irritated. On 09Feb2021, the back of her neck and her shoulders also started to itch, and they were red. Realized it could be from the vaccine, states she looked at her body, it was red, can't tell if it was because she scratched or a reaction. States now the back of her neck and shoulders have started itching, states it was little, red and bumpy. The clinical outcome of the event redness was unknown, and itch was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus
Clinical narrative: experienced itchiness around her legs; her arm felt heavy; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), Dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 16:00 (Batch/Lot Number: EM9809) as DOSE 1, SINGLE for Covid-19 immunization. Medical history included allergy, heart burn, she is allergic to Shellfish, she is allergic to eggs, she is allergic to nuts, she is allergic to Penicillin from an unknown date and unknown if ongoing. She provided relevant family history as heart issues and diabetes. Concomitant medication included Escitalopram oxalate (LEXAPRO); Bupropion hydrochloride (WELLBUTRIN) taken for unspecified indication; Famotidine (PEPCID [FAMOTIDINE]); Omeprazole (PRILOSEC [OMEPRAZOLE]) taken for Dyspepsia. The patient experienced Itchiness around her legs on 09Feb2021 17:15, Her arm felt heavy on 09Feb2021 16:45. Patient took Benadryl for therapeutic measures as a result of experienced itchiness around her legs, her arm felt heavy. It was reported that, she had her first dose of the covid vaccine at 4PM yesterday then at 5:15PM or 5:30PM she started feeling itchiness around the leg and felt a heavy arm. She took Benadryl and felt better. The product is the Covid 19 Vaccine. Patient clarified that her First Dose was on 09Feb2021 4PM, then at 5:15PM she started to notice the itchiness around both legs. The heaviness was in the Right Arm and started around 4:45PM, she adds that she feels the heaviness in the same arm that she received the injection. She took the Benadryl around 6:15PM. Patient stated that the vaccine Lot was on a sticker posted on the card. Her scheduled second dose is on 02Mar2021. Patient stated that she has had no positive covid test or positive antibody test prior to the vaccine. She has had no other vaccines on the same day as her covid vaccine and no vaccines in the last 4 weeks. She did not have to have any visit to the ER or physician office. Patient stated that she was just a little afraid to get the second dose and wants to know if it was okay. Outcome of the event experienced Itchiness around her legs was recovered on 09Feb2021, and not recovered from her arm felt heavy.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy; body rash; This is a spontaneous report from a contactable consumer. A 67-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6201) via an unspecified route of administration, in left arm on 12Feb2021 at 13:30 as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. patient was allergic to meclomen, phenergan, promethazine, nickel. The patient's concomitant medications included ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 01:00 PM the patient experienced itchy body rash. No treatment was received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not resolved.  Follow-up (31May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contraindicated product administered, Rash pruritic
Clinical narrative: Itchy; body rash; This is a spontaneous report from a contactable consumer. A 67-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6201) via an unspecified route of administration, in left arm on 12Feb2021 at 13:30 as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. patient was allergic to meclomen, phenergan, promethazine, nickel. The patient's concomitant medications included ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 01:00 PM the patient experienced itchy body rash. No treatment was received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not resolved.  Follow-up (31May2021): Follow-up attempts completed. No further information expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Macule, Nausea, Pruritus
Clinical narrative: she started really itching; red spots one on each finger and each arm; nausea; she can't really sleep; This is a spontaneous report from a contactable consumer (patient). via information team. An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry Date: Unknown), via an unspecified route of administration in the right arm on 28Jan2021 about 15:00 ( at the age of 87-years) as dose 1, single for COVID-19 immunisation. The patient medical history included allergy to penicillin. Patient had no concomitant medications. There was no history of any previous immunization with the Pfizer vaccine considered as suspect nor any prior vaccinations within 4 weeks or additional vaccines administered on same date of the pfizer suspect vaccines. After vaccination, the patient was doing fine until around 13Feb2021 when she started really itching, red spots one on each finger and each arm, nausea, and can't really sleep. The events did not require any emergency room or physician office visit or hospitalization. No relevant tests were done. She was due to receive her second dose of vaccine on 19Feb2021. She asked if this was normal side effect and whether she should receive her 2nd dose of the Pfizer Covid vaccine if she suspects a non-immediate allergic reaction about a week later. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling face
Clinical narrative: face became very red and warm, and became very swollen and somewhat itchy.; face became very red and warm, and became very swollen and somewhat itchy.; face became very red and warm, and became very swollen and somewhat itchy.; face became very red and warm, and became very swollen and somewhat itchy.; This is a spontaneous report from a contactable consumer (patient). This 67-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201 and expiry date was not provided) via an unspecified route of administration, in left arm, on 13Feb2021 at 13:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation, at Health Clinic. Patient's medical history included Fibromyalgia, Hypertension and Hypothyroid. Patient had no Known allergies. Concomitant medications included alprenolol hydrochloride (ATENENOL), lorazepam (ATIVAN), duloxetine hydrochloride (CYMBALTA), hydrocodone bitartrate, paracetamol (NORCO), bupropion hydrochloride (WELLBUTRIN) and CEL (within two weeks of vaccination). Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID prior vaccination. Patient had not been tested for COVID, post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL1283 and expiry date was not provided) via an unspecified route of administration, in left arm, on 16Jan2021 at 02:30 PM (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Patient reported that on 14Feb2021 at 12:00 PM, her face became very red and warm, and became very swollen and somewhat itchy. It is the same today, 48 hours after my 2nd vaccine. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: my husband was itching; This is a spontaneous report from a contactable Consumer. This Consumer (patient's wife) reported for a Male patient (husband). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 27Jan2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that her husband and she received the 1st dose on 27Jan2021, our second dose was scheduled for tomorrow. The day we got the 1st dose, about 40 min later, on 27Jan2021, her husband (patient) was itching, it was not aggressively itching, he itched throughout the evening, not aggressively just all over kind of itch. He had no hives or rash and by the evening the same day it was gone by morning and like she said he wasn't like digging off his skin itchy but just like sporadically having an itch, just that. Reporter stated do you think that he should get the next vaccine and if he did, like have Benadryl on his hand, what was the protocol with that because she was trying to get in it reviews about that. She had mixed recommendations on what he should do, our family doctor said he should get the 2nd dose and to stay 30 min instead of 15 min and to take Benadryl after injection and she just wanted to know because itching is not technically on the list and it did not testify. The allergist did not think he should get the second dose, that if the reaction was within 4 hours, he should not get it. Although people told her it's not a severe reaction, but with second dose could be worse. She wanted to know what Pfizer thought about him getting the 2nd dose. Outcome of the event was recovered on an unspecified date.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy and rash in my body; Itchy and rash in my body; This is a spontaneous report from a contactable Other HCP (patient herself). A 45-years-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via unspecified route of administration, administered in left arm, on 27Jan2021 12:00 (age at vaccination: 45) as dose number unknown, single for Covid-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility. The patient was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. She had no known allergies. The patient took no other vaccines in four weeks of vaccination and no other medications in two weeks of vaccination. The patient was not tested for COVID prior to post vaccination. The patient experienced itchy and rash in my body, still with the rash on 29Jan2021 08:00 PM. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prednisone was given was treatment. The outcome of the events was not recovered.   Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Urticaria
Clinical narrative: Has flares up a little in the evening; he developed hives on both arms/Hives on both forearms; he developed itching on the arms/Arm started itching; This is a spontaneous report from a contactable consumer.  A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6201; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in right arm on 08Feb2021 at 14:00 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient had no family medical history. The patient concomitatnt mediaction were reported as none. The pateint previously received aloe (aloe extract) for itching and inflammation; influenza virus vaccine in Nov2020 and expereinced sore arms; pneumococcal vaccine in Nov2020 and expereinced sore arms. The patient received Levofloxacin in Jun2019 and expereinced hives. It was reported that patient had hives before from an antibiotic, Levofloxacin, which was much more severe. Hives were on legs, arms, and everywhere. Aloe can control the itching and the aloe kept the inflammation down. Experienced this 1.5 years ago and discovered that aloe works. Indication: Notified by medical provider and because patient was over 65 he was eligible to set up an appointment. Only thing that might be relevant was the Levofloxacin and if that has a similar product in it as the COVID-19 Vaccine. Reaction occurred in Jun2019. Only took Levofloxacin for a few days and broke out in hives. Believed he discarded the Levofloxacin. Clarified Aloe was over the counter. On 12Feb2021, patient developed itching on the arms. On 13Feb2021, patient developed hives on both arms. It was reported that, patient was able to manage adverse events with lotion. Considering that the adverse events showed up 4 days later, patient wanted to Knew that, was it safe to take the second dose. On 17Feb2021, Patient was sure that he had a side effect from the COVID-19 vaccine. It was reported that, hives have been manageable and patient had been putting Aloe on it. Used it a couple times a day. Keeps the itch down. Has flares up a little in the evening, but it was manageable. It was almost all but disappeared by now, Knew what hives could turn into. Wanted to see if it makes sense to get the second dose. The outcome of the events were recovering.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding
Clinical narrative: spotting; having cramps like contractions; This is a spontaneous report from a contactable Consumer (patient's husband). A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date in 2021 (about two weeks ago from the report date) as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date in 2021, after receiving second dose of vaccination, patient experienced spotting and was having cramps like contraction. As per reporter patient was patient was supposed to be starting her period but was spotting and was having cramps like contraction. Reporter asked could this be from the vaccine. Outcome of the events were unknown. Reporter declined transfer to safety.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching rash; rash; This is a spontaneous report from a contactable consumer.   A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269, Expiration date was not provided), via an unspecified route of administration in left arm on 08Feb2021 at 09:40 AM (at the age of 76-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history included (including any illness at time of vaccination) was Parkinson's. The family medical history relevant to AE(s) was reported as no. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: 31May2021), via an unspecified route of administration in left arm on 18Jan2021 (at the age of 76-year-old) as a dose 1, single for COVID-19 immunisation. No Prior vaccinations (within 4 weeks). History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. On 09Feb2021, at 02:30 Am, the Rash and itching started around early 2:30AM this morning. The rash woke him up this morning, it started with the itch. The reporter confirmed the rash and itching started 09Feb2021. It was reported that, the patient was called about the Pfizer Covid Vaccine. Stated that, he woke up this morning with a bad rash and bad itch on most of the body. The reporter clarified that, he already had his first dose, however this event occurred after the second dose. The rash and itching started around early 02:30 AM this morning. The rash woke him up this morning, it started with the itch, the reporter confirmed that, the rash and itching was started on 09Feb2021. He woke up this morning with a bad rash and bad itch on most of the body. He Received the vaccine 08Feb2021 morning. Stated that, he called because he would just like to get this itch over with. Stated that, he had no issues with vaccines in the past. He would like to know how to get rid of this. The caller was referred to his primary care doctor. The caller stated that, he will get treatment from his primary care physician. Stated that, the patient has not been in the emergency room and has not seen any doctor about this yet. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: she started her period on 13Feb2021 at 09:00. She reported that this was unexpected since it was two weeks early and her body was mid cycle; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution injection; Batch/Lot Number: EL9267 and expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 11:45 (at the age of 38-years-old) for COVID-19 immunisation. Medical history included acid reflux. The patient had no known allergies. The patient did not any take vaccine in four weeks. The patient did not have covid prior to vaccination. Concomitant medications included pantoprazole, cyanocobalamin (B12 INJECTION) and citalopram (IC CITALOPRAM). The patient was not tested for COVID post vaccination. The patient reported that 20 hours after she received her vaccination, she started her period on 13Feb2021 at 09:00. She reported that this was unexpected since it was two weeks early and her body was mid cycle. She was not on any form of birth control, however, her cycle was regular and predictable. The outcome of the event was reported as recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Had a big circle and itchiness.; This is a spontaneous report from a non-contactable consumer (patient), from a Pfizer sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 for COVID-19 immunization on an unspecified date. It was reported that, patient got second covid shot. On an unspecified date had a big circle and itchiness. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Pruritus
Clinical narrative: Extremely hot and light headed immediately after vaccine was administered. Few hours later started itching all over. Still itching 2 days later.; Extremely hot and light headed immediately after vaccine was administered. Few hours later started itching all over. Still itching 2 days later.; Extremely hot and light headed immediately after vaccine was administered. Few hours later started itching all over. Still itching 2 days later.; This is a spontaneous report from a non-contactable consumer (Patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 10Feb2021 (at the age of 50-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had known allergies. The patient did not receive any vaccines within four weeks prior to the vaccination. On 10Feb2021, on the same day of vaccination, the patient experienced extremely hot and light headed immediately after vaccine was administered. Few hours later started itching all over. Patient still itched 2 days later. The patient did not receive any treatment for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Paraesthesia
Clinical narrative: tingling in all of his extremities; abdominal cramping; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling in all of his extremities, abdominal cramping. The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Pins and needles sensation all throughout the body; Burning on finger; 4th finger on left hand; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: EM9809, Expiry date: 30Jun2021) via an unspecified route of administration, in the left upper arm on 08Feb2021 at 09:15 (at the age of 66-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included 'high blood pressure when she eat salty food's, 'penicillin had no effect on patient' and 'Levaquin affects nerves'. Concomitant medications were not provided. Patient had no relevant family medical history. The patient did not receive any other vaccines within 4 weeks prior to or on the date of COVID vaccine nor any other medications within 2 weeks of vaccination. Patient had no adverse events following prior vaccinations. Patient had no covid prior vaccination. On 08Feb2021, by the time the patient came home after the vaccination at night she experienced burning on finger; 4th finger on left hand and stated it went away within a day. On 09Feb2021 the patient experienced pins and needles sensation all throughout the body for 3 weeks. The patient further stated that "she hasn't gotten the second shot; it has been 4 weeks and 2 days since her 1st vaccine" because she has heard it was stronger. She was in a quandary because of first reaction she doesn't know how the second vaccine will effect her body. Patient was not covid tested post vaccination. No emergency room or physician office were required for the events. No treatment was provided for the events. Outcome of the event of 'burning on finger; 4th finger on left hand' was recovered on 10Feb2021, the event of pins and needles sensation all throughout the body recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pruritus, Urticaria
Clinical narrative: Whole boy itchy skin; Skin felt like sun tan burn; Headache; Some itchy welts on stomach; This is a spontaneous report from a contactable consumer (reporting himself). This 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 17Feb2021 at 11:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient received unspecified medications in two weeks of vaccination. The patient did not experienced COVID prior to vaccination. The patient did not test for COVID post vaccination. The patient was allergic to penicillin. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On 17Feb2021 at 14:00, the patient experienced whole boy itchy skin, skin felt like suntan burn, headache, some itchy welts on stomach which was more severe than first dose. The evets resulted in doctor or other healthcare professional office/clinic visit. The patient took allergy consultation, prescriptions and Benadryl as treatment medication for the events. The patient not recovered from the events.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Whole boy itchy skin; Skin felt like sun tan burn; Headache; Some itchy welts on stomach; This is a spontaneous report from a contactable consumer (reporting himself). This 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 17Feb2021 at 11:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient received unspecified medications in two weeks of vaccination. The patient did not experienced COVID prior to vaccination. The patient did not test for COVID post vaccination. The patient was allergic to penicillin. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On 17Feb2021 at 14:00, the patient experienced whole boy itchy skin, skin felt like suntan burn, headache, some itchy welts on stomach which was more severe than first dose. The evets resulted in doctor or other healthcare professional office/clinic visit. The patient took allergy consultation, prescriptions and Benadryl as treatment medication for the events. The patient not recovered from the events.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.