chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer. A female patient of unspecified age received BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the reporter's mother experienced rashes after the COVID-19 vaccine. The clinical outcome of rashes was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site after COVID vaccine; This is a spontaneous report received from a contactable consumer (patient). This patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration on an unknown date for COVID-19 vaccination. No medical history was reported. Concomitant medications were not reported. On an unknown date, the patient experienced soreness at the injection site after COVID vaccine. The clinical outcome of soreness at the injection site was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: after 5days she had a hard time breathing and her heartbeat is rising for 1hour and then the 6th day same case, difficulty breathing and heartbeat rising for 3hours; after 5days she had a hard time breathing and her heartbeat is rising for 1hour and then the 6th day same case, difficulty breathing and heartbeat rising for 3hours; This is a spontaneous report received from a Pfizer Sponsored Program Support. A contactable consumer (patient) reported this female patient of unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 16Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 21Feb2021, 5 days after the vaccine, she had a hard time breathing and her heartbeat was rising for one hour. The 6th day she had difficulty breathing and heartbeat was rising for 3 hours. The patient was worried about taking the second dose of BNT162B2. The outcome of difficulty breathing and heartbeat was rising was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site beginning approximately 5 hours after COVID-19 vaccination.; This is a spontaneous report from a contactable consumer.  A 62-year-old male patient received bnt162b2 (BNT162B2, Lot Number: EL 3247), via an unspecified route of administration on an unspecified date (at the age of 62 years) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced soreness at injection site beginning approximately 5 hours after COVID-19 vaccination on an unspecified date with outcome of unknown.    Information related to batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from the Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration on 11Feb2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pain on 03Mar2021. The caller (patient)sated that "had her first dose 11Feb2021 and experienced pain after 20days from the 1st dose. She is also scheduled to have her 2nd dose on March 11 which is more than 21days from the 1st dose." The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from Pfizer regarding a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 05Mar202, the patient experienced a headache. Clinical outcome of the event of headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the left arm; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Mar2021, the patient experienced soreness in the left arm after the vaccine. The outcome of soreness in the left arm was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: She was sick; Missed her second dose within the time frame (3 weeks apart); This is a spontaneous report from a contactable consumer (patient) via Pfizer. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she missed her second dose within the time frame of 3 weeks because she was sick and inquired if she could proceed with her second dose. She also inquired if the second dose was stronger than the first dose. The clinical outcome of she was sick was unknown. The clinical outcome of she missed her second dose within the time frame was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL3247) via an unspecified route of administration on 18Feb2021 at 11:25 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Type 2 diabetes since Sep2017. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received dose 1 of BNT162B2 (lot number EL3247; expiration date May2021) intramuscularly on 27Jan2021 as a single dose in the left arm for COVID-19 immunization. Concomitant medications included metformin from 3 or 4 years ago as of 2021 for an unspecified indication, colecalciferol from over 10 years ago as of 2021 for an unspecified indication, omega-3 fatty acids from at least 4 years ago as of 2021 for an unspecified indication. The patient previously received azithromycin on an unspecified date for an unspecified indication and experienced full body itchy hives/rash. On 18Feb2021, about six hours after the second dose of BNT162B2 the patient experienced sore arm. The following day (also reported as 48 hours later) the patient experienced fatigue. The patient was not hospitalized for the events and did not visit a physician's office or emergency room for the events. The patient did not receive any treatment for the events. The outcomes of sore arm and fatigue were recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm was sore; This is a spontaneous report from a contactable consumer (patient) via Pfizer. This female patient of unspecified age received a dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she received the COVID-19 vaccine yesterday (as of 05Mar2021) and four to five hours later her arm was sore, especially when lifting her arm. She reporting she had been using an ice pack. The clinical outcome of her arm was sore was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Ear pruritus, Hypersensitivity, Hypoaesthesia
Clinical narrative: allergic reaction; Face went numb; Hard to swallow; Voice got hoarse; Inside of her ears got very itchy; Scalp also got itchy; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 24Feb2021 (Batch/Lot Number: EM9809) (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma since many years ago, but it was under control and fibromyalgia since many years ago. Concomitant medications included pregabalin at 250mg daily (100 mg once a day and 150 mg second part of the day) for fibromyalgia, budesonide, formoterol fumarate (SYMBICORT) inhalation powder, at 2 inhalations twice a day for asthma, escitalopram at 20mg tablet once a day for asthma, rosuvastatin calcium at 5mg tablet once a day for an unspecified indication, venlafaxine hcl at 50mg tablet twice a day for an unspecified indication, montelukast sodium at 10mg once a day for an unspecified indication and ciclosporin (RESTASIS) eye drops at one drop in each eye, twice a day for an unspecified indication. The patient was previously received the first dose of BNT162b2 (Lot number: EL9262), via an unspecified route of administration on the left arm on 03Feb2021 15:59 (at the age of 58-years-old) as a single dose for COVID-19 immunization and experienced tip of her tongue, lips, and part of cheek close to her mouth went numb on 03Feb2021, 45-60 minutes after the shot and the patient was recovered from the events on 03Feb2021 as they went away. Within 5 minutes after getting the vaccine shot on 24Feb2021, the patient had a much bigger allergic reaction and she experienced face went numb, it was hard to swallow, her voice got hoarse, the inside of her ears got very itchy and her scalp also got itchy. The patient was treated with diphenhydramine (BENADRYL) at 25mg tablet that night. The outcome of events, allergic reaction, face went numb, hard to swallow, voice got hoarse, inside of her ears got very itchy and scalp also got itchy was recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122392 first dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: allergic reaction; Face went numb; Hard to swallow; Voice got hoarse; Inside of her ears got very itchy; Scalp also got itchy; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 24Feb2021 (Batch/Lot Number: EM9809) (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma since many years ago, but it was under control and fibromyalgia since many years ago. Concomitant medications included pregabalin at 250mg daily (100 mg once a day and 150 mg second part of the day) for fibromyalgia, budesonide, formoterol fumarate (SYMBICORT) inhalation powder, at 2 inhalations twice a day for asthma, escitalopram at 20mg tablet once a day for asthma, rosuvastatin calcium at 5mg tablet once a day for an unspecified indication, venlafaxine hcl at 50mg tablet twice a day for an unspecified indication, montelukast sodium at 10mg once a day for an unspecified indication and ciclosporin (RESTASIS) eye drops at one drop in each eye, twice a day for an unspecified indication. The patient was previously received the first dose of BNT162b2 (Lot number: EL9262), via an unspecified route of administration on the left arm on 03Feb2021 15:59 (at the age of 58-years-old) as a single dose for COVID-19 immunization and experienced tip of her tongue, lips, and part of cheek close to her mouth went numb on 03Feb2021, 45-60 minutes after the shot and the patient was recovered from the events on 03Feb2021 as they went away. Within 5 minutes after getting the vaccine shot on 24Feb2021, the patient had a much bigger allergic reaction and she experienced face went numb, it was hard to swallow, her voice got hoarse, the inside of her ears got very itchy and her scalp also got itchy. The patient was treated with diphenhydramine (BENADRYL) at 25mg tablet that night. The outcome of events, allergic reaction, face went numb, hard to swallow, voice got hoarse, inside of her ears got very itchy and scalp also got itchy was recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122392 first dose
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Minor achy; flu like symptoms; This is a spontaneous report received from a non-contactable consumer. A male patient of unspecified age received a dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced minor achy and flu like symptoms. The clinical outcomes of minor achy and flu like symptoms were unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; Fever 101 degree celcius; CHILLS; sore arm; This is a spontaneous report from received from a contactable consumer, the patient. This consumer reported different events after each dose of the same product for the same patient; This is the second of two reports. A 47-year-old adult female received the second dose of intramuscular BNT162b2 (solution for injection; Lot EL3249 expiry 31May2021) as a single dose in the right deltoid on 20Jan2021 at 14:00 (at 47-years-old) for COVID-19 immunisation. There was no medical history or concomitant medications reported. The patient previously received her first dose of intramuscular BNT162b2 (Lot EK5730) on 30Dec2020 (at 46-years-old) and donated blood seventeen days later and showed no antibodies. The patient reported that she received the second dose of vaccine on 20Jan2021 at 14:00 and by 21Jan2021 02:00, reported as within twelve hours, she had a sore arm, 101degree Centigrade fever, and body aches and chills. The patient denied any emergency room visit or physician's office visit and was not admitted to the hospital for the events. Post-vaccination antipyretic use on 20Jan202 included oral acetaminophen (TYLENOL) 1000mg, and oral ibuprofen (MOTRIN) 600mg. Treatment was received for the events. The outcome of the events sore arm, 101degree Centigrade fever, and body aches and chills was recovered on unspecified date(s) in 2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056901 PFIZER (Same patient/product; first dose, different event separated in time)
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: arms are swelling/swollen arm; starting to itch; where the shot was put in and is turning red; This is a spontaneous report from a Sponsored Program  from a contactable consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2, via an unspecified route of administration, on an unspecified date as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 on an unspecified date for COVID-19 immunization. The patient reported that she thinks she is having some reactions to the second dose. Her arms are swelling and starting to itch and it's like it is already swollen which you can see where the shot was put in and is turning red. The clinical outcome of the events arms are swelling/swollen arm, starting to itch and where the shot was put in is turning red, was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: the next day the left hand, where she got the shot, turned numb; This is a spontaneous report received from a sponsored program. A contactable consumer (patient) reported this female patient of unspecified age received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 03Mar2021, the left hand where she got the shot turned numb. The patient tried to loosen her arm to relieve it, then it happened again "yesterday." It did not last that long; it would only last for a few seconds. The outcome of left hand where she got the shot turned numb was recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she was sick; This is a spontaneous report from a contactable consumer (the patient) from a sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 18Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she couldn't get the second one (dose), because she was sick. The second dose was tomorrow. She wanted to know if that was okay. The outcome of sick was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Rash
Clinical narrative: headache; chills; body aches; rash underarms and stomach; This is a spontaneous report received from. a contactable male consumer (patient) This is a spontaneous report via a Pfizer sponsored program from a contactable consumer, the patient. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) intramuscularly on 21Feb2021 as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. On 21Feb2021, the patient experienced headache, chills, body aches, and in 2021, he experienced rash underarms and stomach.  The patient recovered from the events, headache, chills, and body aches. Outcome of the event, rash underarms and stomach was unknown.    The lot number for the vaccine, BNT162B2, was not provided and has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program. This female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19  VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The clinical outcome of the sore arm was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) :PFIZER INC-2021269107 same patient, same drug, different event
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: Nauseous; Sick for 2 days; This is a spontaneous report received from a contactable consumer (patient). This female patient of unspecified age received dose 2 of BNT62B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unknown date for COVID-19 immunization and experienced sore arm. While calling to refill pregabalin (LYRICA) the patient reported on an unspecified date after dose 2 of BNT162B2 she was sick for 2 days and was nauseous. The outcomes of sick for 2 days and nauseous were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea
Clinical narrative: diarrhea; felt "a strike on her chest like being shocked in the heart"; This is a spontaneous report received from a Pfizer -sponsored Program. A contactable consumer reported a 70-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included cancer came back 1.5 years ago (as of 2021), losing her hair, bald spots on her head, lungs filling up with fluid, hard for her to breathe, and gone to the hospital twice to have her lungs drained over the last 1.5 years. Concomitant medications included palbociclib (IBRANCE) from an unspecified date for an unspecified indication. On an unspecified date after dose 1 of BNT162B2 the patient felt a strike on her chest like being shocked in the heart and diarrhea. The outcomes of felt a strike on her chest like being shocked in the heart and diarrhea were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Post vaccine chills; fever; aches; This is a spontaneous report from a contactable consumer. An adult patient in 5th decade (in early 40's) of unspecified gender received the first dose of BNT162B2 (solution for injection, lot number/expiration date: not provided) via an unspecified route on an unspecified date as a single dose for COVID-19 immunization. The Patient medical history and concomitant medications were not reported. On an unspecified date, the patient had post vaccine chills, fever and aches. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased
Clinical narrative: experienced a striking decrease of my diabetes since my shots; This is a spontaneous report received from a contactable physician (reporting for herself) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an un-specified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that have you noticed decreases in blood sugar levels after Covid shots. Patient have experienced a striking decrease of her diabetes since her shots. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Platelet count increased, Rash
Clinical narrative: The platelets were still high; she has had a rash for ten days following vaccination/both legs then broke out/ her arms broke out//rash on back of right knee/rash on both legs/rash on both arms/rash is in a cluster on the back of her leg but other parts it is bumps all over; her arm was sore; This is a spontaneous report received from a contactable female consumer (patient)  reported for herself. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9264), via an unspecified route of administration, administered on the right arm, at the age of 69 years, on 25Feb2021 09:20 at a SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer, food allergy to shellfish, contrast media allergy, drug hypersensitivity Macrobid; all from an unknown date and unknown if ongoing. The patient mentioned she was a breast cancer survivor and she had breast cancer 18 years ago. Concomitant medications included acetylsalicylic acid (ASPIRINE); lansoprazole (LANSOPRAZOLE) taken for hiatus hernia; rosuvastatin (ROSUVASTATIN) taken for blood cholesterol increased and metoprolol (METOPROLOL); all start and stop date were not reported. The patient previously took amoxicillin and experienced hypersensitivity. The patient stated she has had a rash for ten days following vaccination. The consumer stated she didn't feel it but then her arm was sore that night. She took some Tylenol and the next day her arm was fine. Then she got a rash that started on the back of her right knee on 06Mar2021; both legs then broke out and on 07Mar2021 her arms broke out. She added she went to see her doctor on Monday 08Mar2021, who checked her platelets. The platelets were still high and that was normal for her for the last six years and her blood showed no infection. She added she has been taking  Benadryl and it is keeping her from itching but the rash was still there. The patient added the rash was in a cluster on the back of her leg but other parts it was bumps all over; on her arms it the rash comes and goes. She was scheduled to receive the second dose on 18Mar2021 but that was one thing she was calling about, should she get the next dose and if she had this reaction and what does she need to do.  Therapeutic measures were taken as a result of her arm was sore (pain in extremity). The outcome of the event platelets were still high was unknown while other events were not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Diarrhoea, Nausea
Clinical narrative: Stomach distended massive stomach pains; Stomach distended massive stomach pains; throat swelling; chills; nausea; diarrhea; This is a spontaneous report from a contactable consumer. A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 25Feb2021 at 13:30 (Batch/Lot number was not reported) at 25-years-old as a single dose for COVID-19 immunization; in a pharmacy or drug store.  The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included allergies: tree nuts and sesame seeds from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE; in two weeks) taken for an unspecified indication, start and stop date were not reported. On 25Feb2021 at 14:00, the patient experienced: stomach distended massive stomach pains (non-serious), throat swelling (non-serious), chills (non-serious), nausea (non-serious), diarrhea (non-serious); al of which required Physician Office Visit and Physician Office Visit; wtth no treatment. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Stomach distended massive stomach pains; Stomach distended massive stomach pains; throat swelling; chills; nausea; diarrhea; This is a spontaneous report from a contactable consumer. A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 25Feb2021 at 13:30 (Batch/Lot number was not reported) at 25-years-old as a single dose for COVID-19 immunization; in a pharmacy or drug store.  The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included allergies: tree nuts and sesame seeds from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE; in two weeks) taken for an unspecified indication, start and stop date were not reported. On 25Feb2021 at 14:00, the patient experienced: stomach distended massive stomach pains (non-serious), throat swelling (non-serious), chills (non-serious), nausea (non-serious), diarrhea (non-serious); al of which required Physician Office Visit and Physician Office Visit; wtth no treatment. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cerebral disorder, Chest discomfort, Dizziness, Dysphemia
Clinical narrative: affecting my brain; Couldn't articulate words clearly/thinking a particular word but would say a different one; stuttering; brain fog; feeling lightheaded and off balance; feeling lightheaded and off balance; pressure on my chest which made breathing slightly more labored; pressure on my chest which made breathing slightly more labored; pressure in my ears and throat; pressure in my ears and throat; my palms turned red; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 72-year-old, via an unspecified route of administration, administered in left arm on 01Mar2021 13:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included left bundle branch block, high cholesterol, and known allergies: intolerance to wheat, corn, peanuts, walnuts, sesame seeds. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient couldn't articulate words clearly due to stuttering. She would be thinking a particular word but would say a different one. This has subsided, but she was concerned as to whether she should take the second one as it's apparently affecting her brain. Also, mild symptoms of brain fog, feeling lightheaded and off balance, pressure on my chest which made breathing slightly more labored, pressure in my ears and throat, my palms turned red. All the events occurred on 01Mar2021 at 13:45. No treatment was received for the events. The outcome of the events couldn't articulate words clearly/thinking a particular word but would say a different one and stuttering was recovered on Mar2021 and recovering for the rest of the events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear discomfort, Feeling abnormal, Oropharyngeal discomfort, Palmar erythema
Clinical narrative: affecting my brain; Couldn't articulate words clearly/thinking a particular word but would say a different one; stuttering; brain fog; feeling lightheaded and off balance; feeling lightheaded and off balance; pressure on my chest which made breathing slightly more labored; pressure on my chest which made breathing slightly more labored; pressure in my ears and throat; pressure in my ears and throat; my palms turned red; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 72-year-old, via an unspecified route of administration, administered in left arm on 01Mar2021 13:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included left bundle branch block, high cholesterol, and known allergies: intolerance to wheat, corn, peanuts, walnuts, sesame seeds. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient couldn't articulate words clearly due to stuttering. She would be thinking a particular word but would say a different one. This has subsided, but she was concerned as to whether she should take the second one as it's apparently affecting her brain. Also, mild symptoms of brain fog, feeling lightheaded and off balance, pressure on my chest which made breathing slightly more labored, pressure in my ears and throat, my palms turned red. All the events occurred on 01Mar2021 at 13:45. No treatment was received for the events. The outcome of the events couldn't articulate words clearly/thinking a particular word but would say a different one and stuttering was recovered on Mar2021 and recovering for the rest of the events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: affecting my brain; Couldn't articulate words clearly/thinking a particular word but would say a different one; stuttering; brain fog; feeling lightheaded and off balance; feeling lightheaded and off balance; pressure on my chest which made breathing slightly more labored; pressure on my chest which made breathing slightly more labored; pressure in my ears and throat; pressure in my ears and throat; my palms turned red; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 72-year-old, via an unspecified route of administration, administered in left arm on 01Mar2021 13:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included left bundle branch block, high cholesterol, and known allergies: intolerance to wheat, corn, peanuts, walnuts, sesame seeds. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient couldn't articulate words clearly due to stuttering. She would be thinking a particular word but would say a different one. This has subsided, but she was concerned as to whether she should take the second one as it's apparently affecting her brain. Also, mild symptoms of brain fog, feeling lightheaded and off balance, pressure on my chest which made breathing slightly more labored, pressure in my ears and throat, my palms turned red. All the events occurred on 01Mar2021 at 13:45. No treatment was received for the events. The outcome of the events couldn't articulate words clearly/thinking a particular word but would say a different one and stuttering was recovered on Mar2021 and recovering for the rest of the events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive, Wheezing
Clinical narrative: Wheezing a little bit; Coughing all the time with Asthma; Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported, expiration date: not reported via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 07:00 (at the age of 78-years-old) as single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing Asthma causes patient to have wheezing a little bit, which she has all the time and she also has coughing all the time with Asthma, ongoing diabetes mellitus (Onset date unknown other than more than 15 years ago and is ongoing). There were no concomitant medications reported. The patient experienced tested positive for covid-19 on 14Mar2021, wheezing a little bit and coughing all the time with asthma on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Mar2021 COVID-19 test. The outcome of event tested positive for covid-19 was not recovered and wheezing a little bit and coughing all the time with asthma was unknown.  Follow-up activities have been completed and information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Vaccination site pain, Wrong technique in product usage process
Clinical narrative: this person jabbed her so hard with the shot and the caller jumped; pain around the injection site for 7 weeks; Arm hurts; It's very hard for her to open her car door or lift her up/ hard to lift or move her arm; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) intramuscular in left arm on 29Jan2021 in the morning at age of 67-year-old at single dose for COVID-19 immunisation. The vaccine was not administered at military facility. The patient had no medical history. There were no concomitant medications (reported as no other products received). The patient previously took the first dose of BNT162B2 intramuscular in left arm on 08Jan2021 at age of 67-year-old for COVID-19 immunisation and experienced no adverse event (reported as "she was fine"). The patient experienced arm hurts and pain around the injection site for 7 weeks on 29Jan2021. The events did not require a visit to Emergency Room or Physician Office. The caller was calling in regard to the Pfizer COVID-19 vaccine. She didn't know who the person was who gave her the shot, she didn't know if she was a nurse or what she was, but the person had a nurse beside her who told her to give the shot. The caller explained she recognized the nurse, beside the person that actually help administered the second dose. The nurse was the people who help administered the first dose, but she let this other lady gave the second dose to her, she did not know why. Caller explained this person jabbed her so hard with the shot and the caller jumped. The nurse knew something was wrong and asked "what did you do to her". She stated it's been 6 weeks at the time of report, and her arm still hurts. When she pressed down on her arm, it hurts. It hurts on top of her arm, underneath her arm. She didn't know what this is. It's been a long time her arm has felt this way, her arm should be getting better by now. She stated she felt the pain right away and her arm didn't get better. It's very hard to lift or move her arm. When she pressed down where she received the shot (injection site), it still hurts all along there. It's very hard for her to open her car door or lift her up. It should have gone away already. She mentioned seeing "MR" on her vaccine record card and also the date 27Jan, but she clarified this was the date of when she could have received it. She could have received it between the time frame of 27Jan- 31Jan 2021. She got it on 29Jan2021. She further explained she just kept touching the injection site and it just hurts. It's very hard to lift her arm and underneath arm. She didn't understand what this was, and she hoped there was no hematoma or anything. No relevant test was taken for the patient. The outcome of event "arm hurts" was not recovered, of other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphonia, Balance disorder, Chills, Disturbance in attention, Dizziness
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Eye pruritus, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.