chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient's daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: Cold; Runny nose; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program .  An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (lot number and expiry date: unknown) at the age of 80-years-old, as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 27Feb2021, the patient experienced cold and runny nose. Outcome of the events was unknown. Patient wanted to know if she could take the 2nd dose on 03Mar2021.  No follow-up attempts are possible. Information on lot/batch number could not be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included unspecified supplements, taken 4 days after 1st dose. The patient experienced sore arm on an unspecified date. Outcome of the event was unknown. The patient will receive 2nd dose this Friday, and he would like to know if any herbal products/vitamins/supplements can interact with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: sore arm; swollen lymph nodes under arm pit on same side an injection; headache; fatigue; This is a spontaneous report from a non-contactable consumer (patient). This report was received via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced sore arm, swollen lymph nodes under arm pit on same side an injection, headache and fatigue on an unspecified date after second dose of Pfizer Covid vaccine with outcome of recovered (duration reported as 3 days).  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: a little bit of nausea; tiredness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 (lot number and expiry date unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced a little bit of nausea and tiredness. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Feb2021 (lot number and expiry date: unknown) as dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced very slight fatigue on unspecified date in Feb2021, after the 1st dose. Outcome of the event fatigue was unknown. The patient already missed the 2nd dose schedule last 28Feb2021 and would like to reschedule.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Lymphadenopathy
Clinical narrative: swollen lymph node under arm; Severe abdominal pain; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 08:45 as dose 2, single for covid-19 immunisation.  The patient's medical history included systemic lupus erythematosus from Jan2011 and ongoing Verbatim: lupus, hashimotos from Mar2011 and ongoing, food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9267, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 11Feb2021 as dose 1, single for COVID-19 immunization. The patient had a couple of uncommon reactions, and she wants to make sure there's nothing she can do. The second vaccination hit her pretty hard.  On Friday the caller had the second vaccine and on 08Mar2021, she noticed a large lump under her arm were she got shot in, she thinks her lymph node was swollen and that was really sore. The patient also had abdominal pain which started on 08Mar2021 Friday at 10 in the morning and her shot was given at 8:45 that day. If the lymph node swelling was from the vaccine, the caller figured that it would have shown up rather quickly and not a delayed reaction.The outcome of events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Sinus headache
Clinical narrative: Continued severe migraine/sinus headaches; Continued severe migraine/sinus headaches; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 65-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6203, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 26Feb2021 at 03:00 am (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The patient's medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), ongoing migraines and known allergy to CT (Computed tomography) dye. Concomitant medication or other medication the patient received in two weeks included galcanezumab gnlm (EMGALITY) injection taken for migraines. The patient previously took compazine [prochlorperazine edisylate], omnicef [cefdinir] and reglan [metoclopramide] and experienced known allergies to it. The facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27Feb2021, the patient experienced continued severe migraine/sinus headaches. The patient took migraine and sinus meds for the events. The outcome of the events was not resolved.No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Severe kidney pain; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 12Mar2021 at 15:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Relevant medical history included diabetes and had allergies to medications, food, or other products. Concomitant medications included curcuma longa rhizome/turmeric, cinnamomum verum (CINNAMON) and metformin. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021 (ninth day of vaccine) at 04:00, the patient had severe kidney pain. Therapeutic measures included intake of tylenol. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe kidney pain was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021316651 same reporter/drug/event, different patient;US-PFIZER INC-2021316652 same reporter/drug/event, different patient
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Sleep disorder
Clinical narrative: Severe pain go through stomach/Severe stomach pain; kind of pain on the side of my stomach right about where my hernia is, off and on most of the day; stomach pain all over the area of my stomach; I didn't sleep most of the night, I didn't sleep at all; This is a spontaneous report from a contactable consumer or other non hcp. A 82-years-old female consumer reported for herself that, patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 11Mar2021 (82-year-old at the time of vaccination)  as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Diabetic and hernia from an unknown date and unknown if ongoing. Historical vaccine includes, received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's concomitant medications were not reported. On an unknown date, patient stated, she had kind of pain on the side of my stomach right about where her hernia was, off and on most of the day. And then that night she didn't sleep most of the night, she didn't sleep at all because she just had severe stomach pain all over the area of her stomach. So, patient stated that she have to do have her surgery if it starts to pain and hurt her. And the doctor said that it doesn't necessarily have to be constant. She stated, After the shot she not experienced any side effects what so ever, only that one 2 nights ago. Patient stated, just took Tylenol as treatment till now. The outcome of all events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Fatigue, Flatulence, Nausea
Clinical narrative: Pain at injection site; Severe stomach discomfort; Nausea; Extreme Fatigue; Stomach pains; gas; This is a spontaneous report from a contactable consumer or other non hcp reporting for himself (patient). A 51-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7534, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 21Mar2021 at 15:15 (at the age of 51-year-old) as dose 1, single for covid-19 immunization at other facility. Medical history included High blood pressure and DVT. Patient was allergic to Floxin. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC), rivaroxaban (XARELTO) and azilsartan kamedoxomil (EDARBI). The patient had not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 05:45PM, patient experienced Stomach pains/gas. On 21Mar2021 03:30 PM the patient experienced pain at injection site, severe stomach discomfort, nausea and extreme fatigue. No treatment was received in response to the events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; Severe stomach discomfort; Nausea; Extreme Fatigue; Stomach pains; gas; This is a spontaneous report from a contactable consumer or other non hcp reporting for himself (patient). A 51-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7534, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 21Mar2021 at 15:15 (at the age of 51-year-old) as dose 1, single for covid-19 immunization at other facility. Medical history included High blood pressure and DVT. Patient was allergic to Floxin. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC), rivaroxaban (XARELTO) and azilsartan kamedoxomil (EDARBI). The patient had not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 05:45PM, patient experienced Stomach pains/gas. On 21Mar2021 03:30 PM the patient experienced pain at injection site, severe stomach discomfort, nausea and extreme fatigue. No treatment was received in response to the events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Gastric disorder
Clinical narrative: Severe Gastric Issues - I had the issue for a year in a mild format. After first dose I got really bad but I tried to manage that; Severe Gastric Issues - I had the issue for a year in a mild format. After first dose I got really bad but I tried to manage that; This is a spontaneous report from a contactable consumer or other non hcp.  A 34-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EL6203 expiration date were not reported) via an unspecified route of administration, administered at arm right on 26Feb2021 19:00 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. The patient, medical history included gastric issues from an unknown date and unknown if ongoing (Severe Gastric Issues - I had the issue for a year in a mild format). Concomitant medications included pantoprazole, simeticone (PHAZYME), amitriptyline, vitamin D taken for an unspecified indication, start and stop date were not reported. No pregnancy at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products: No. Location of injection information is available for all vaccines received on the same date. On 20Mar2021, the patient experienced severe gastric issues - she had the issue for a year in a mild format. After first dose she got really bad but she tried to manage that and she thought that was related to the old issue that she had (condition aggravated). No treatment was received for the adverse event. Yesterday, she got the second dose and today she was in pain and she felt burn on her esophagus. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: I am having severe kidney pain/ I mentioned it to my daughter and she too had the same pain.; This is a spontaneous report received from a contactable consumer (patient's mother).  A female patient of unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: Unknown), via an unspecified route, on an unknown date, as a dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had kidney pain. The patients mother mentioned it to her daughter (severe pain in the kidney), and daughter too had the same pain. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021316651 same reporter/drug/event, different patient;US-PFIZER INC-2021305789 same reporter/drug/event, different patient
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Nausea, Pain in extremity
Clinical narrative: Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; Begins with his first dose of vaccine which he states gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient)  A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 16Feb2021 (Age at vaccination: 69 years old) as dose 1, single for covid-19 immunization at health department. The patient medical history included: took pneumonia shots for immunization and flu shots for flu prevention on an unspecified date. Concomitant medication(s) included apixaban (ELIQUIS) tablet taken as blood thinner at 5mg twice a day from 2019 and ongoing. Patient did not take additional vaccines on same date of the Pfizer suspect, patient denied any illness at time of vaccination, no family medical history relevant to events of the patient, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021, the patient experienced events, which begins with his first dose of vaccine which he stated gave him severe diarrhea and nausea, gastrointestinal distress, wore him out, and a sore arm. Nausea, diarrhea, gastrointestinal distress, lasted about a day and worn out and sore arm, lasted about three days per patient. Events did not result in a visit to physician office or emergency room. Outcome of events nausea, diarrhea, gastrointestinal distress was recovered on 17Feb2021 and outcome of events worn out and sore arm was recovered on 19Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Severe hearing problem; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 89-years-old female patient received bnt162b2 (PFIZER COVID-19 vaccine, Formulation: Solution for Injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 20Mar2021 as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination:88-Year-old). Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. Caller stated, "I have a severe hearing problem. My husband and I got our first COVID-19 vaccine on 20Mar2021 and we are scheduled to get our second one on 20Apr2021 which is way over the 3 weeks that I have just read in our literature. So can you help me change. She wanted to reschedule it because it is past 21 days. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: severe abdominal pain; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for a male patient (Husband). A male patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection, Batch Number /Lot Number: Not reported) dose number unknown via unspecified route of administration, administered on unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced severe abdominal pain. It was reported that, patient's wife was going to take him to the hospital. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Fatigue, Irritable bowel syndrome
Clinical narrative: severe abdominal cramping/severity on unrelenting cramping that I am on the floor; diarrhea; vomiting/ everything emptying out and then start intense vomiting; felt "woozy" right after getting the vaccine; fatigue; I have GI issues like IBS kind of stuff; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration on 02Apr2021 16:20 as dose 1, single (at the age of 61-years-old) for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Apr2021, the patient experienced felt "woozy" right after getting the vaccine. On 03Apr2021 04:20, the patient experienced severe abdominal cramping/severity on unrelenting cramping that i am on the floor, diarrhea and vomiting/ everything emptying out and then start intense vomiting. On Apr2021, the patient experienced fatigue and i have gi issues like ibs kind of stuff. The outcome of all the events was unknown.     No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe abdominal cramping/severity on unrelenting cramping that I am on the floor; diarrhea; vomiting/ everything emptying out and then start intense vomiting; felt "woozy" right after getting the vaccine; fatigue; I have GI issues like IBS kind of stuff; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration on 02Apr2021 16:20 as dose 1, single (at the age of 61-years-old) for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Apr2021, the patient experienced felt "woozy" right after getting the vaccine. On 03Apr2021 04:20, the patient experienced severe abdominal cramping/severity on unrelenting cramping that i am on the floor, diarrhea and vomiting/ everything emptying out and then start intense vomiting. On Apr2021, the patient experienced fatigue and i have gi issues like ibs kind of stuff. The outcome of all the events was unknown.     No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Cognitive disorder, Diarrhoea
Clinical narrative: weak; nausea; diarrhea; severe pain in my abdomen feeling like a knife stabbing me mostly left side; chills; headache; mental clarity and can't think straight; This is spontaneous report from a contactable consumer (patient).A female  (age: 68 unit: unknown) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021, as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation and experienced fainted, fell down face forward, busted her lip, blurred vision, rash on arms, back and chest, Joint pain, muscle pain, weak and having to walk with a cane. On01Apr2021, the patient experienced weak, nausea, diarrhea, severe pain in abdomen feeling like a knife stabbing me mostly left side. It was excruciating. On 01Apr2021, the patient experienced chills, headache, mental clarity and couldn't think straight. Started last night of the day of reporting and the patient had some symptoms and needed to talk to someone about what to do about them. The reporter assessed the case as non serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: weak; nausea; diarrhea; severe pain in my abdomen feeling like a knife stabbing me mostly left side; chills; headache; mental clarity and can't think straight; This is spontaneous report from a contactable consumer (patient).A female  (age: 68 unit: unknown) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021, as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation and experienced fainted, fell down face forward, busted her lip, blurred vision, rash on arms, back and chest, Joint pain, muscle pain, weak and having to walk with a cane. On01Apr2021, the patient experienced weak, nausea, diarrhea, severe pain in abdomen feeling like a knife stabbing me mostly left side. It was excruciating. On 01Apr2021, the patient experienced chills, headache, mental clarity and couldn't think straight. Started last night of the day of reporting and the patient had some symptoms and needed to talk to someone about what to do about them. The reporter assessed the case as non serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; This is a spontaneous report from a contactable consumer reported for a female patient (wife) that:  A female patient of unspecified age received bnt162b2 (PFIZER BIONTECH COVID 19 Vaccine, Solution for injection, Batch/Lot no and expiration date not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated after first dose of vaccine she experienced like 3 days of severe diarrhea. At the time of reporting, the outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Migraine
Clinical narrative: extreme headache/migraine next day/severe headache/migraine; foggy head; dizziness; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7534 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Apr2021 at 10:45 AM, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history was reported as none. The patient did not have any known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 03Apr2021 at 06:00 AM, the patient experienced extreme headache/migraine next day, laster 2 days, ibuprofen did not help went to ER on day 3, got IV with migraine cocktail: Toradol, Reglan and Benadryl help with the severe headache/migraine 6 days after the dose of Pfizer vaccine, dizziness and foggy head (3 days already) on an unspecified date in Apr2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was recovered with sequel on an unspecified date in Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate increased, Hypersensitivity
Clinical narrative: severe allergic reactions; dizziness, weakness, rapid heart beat; dizziness, weakness, rapid heart beat; dizziness, weakness, rapid heart beat; This is a spontaneous report from a contactable consumer (patient). A female patient (Age 49; units: Unspecified) received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry date were not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe allergic reactions, dizziness, weakness, and rapid heartbeat. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Extra dose administered, Skin warm, Tenderness
Clinical narrative: 12 days after covid booster and 1 day after flu vaccine the patient's BCG vaccine scar in her L arm became red/hot/tender.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram abnormal, Atelectasis, Chest X-ray abnormal, Chest discomfort, Chest pain
Clinical narrative: Patient stated that her shortness of breath started after she received the booster Pfizer vaccine on 11/12/2021. She denies having issues with the first 2 vaccines. She only had symptoms of a headache with the first 2 vaccine shots. Post booster on 11/12/2021, she has been experiencing shortness of breath,  chest pain, chest heaviness, headache, cough, headaches, and intermittent diaphoresis. She describes her chest pain as "someone is sitting on top of my chest."
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fibrin D dimer, Full blood count, Headache
Clinical narrative: Patient stated that her shortness of breath started after she received the booster Pfizer vaccine on 11/12/2021. She denies having issues with the first 2 vaccines. She only had symptoms of a headache with the first 2 vaccine shots. Post booster on 11/12/2021, she has been experiencing shortness of breath,  chest pain, chest heaviness, headache, cough, headaches, and intermittent diaphoresis. She describes her chest pain as "someone is sitting on top of my chest."
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lung opacity, Metabolic function test, Procalcitonin, Scar
Clinical narrative: Patient stated that her shortness of breath started after she received the booster Pfizer vaccine on 11/12/2021. She denies having issues with the first 2 vaccines. She only had symptoms of a headache with the first 2 vaccine shots. Post booster on 11/12/2021, she has been experiencing shortness of breath,  chest pain, chest heaviness, headache, cough, headaches, and intermittent diaphoresis. She describes her chest pain as "someone is sitting on top of my chest."
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal osteoarthritis, Troponin, Urine analysis
Clinical narrative: Patient stated that her shortness of breath started after she received the booster Pfizer vaccine on 11/12/2021. She denies having issues with the first 2 vaccines. She only had symptoms of a headache with the first 2 vaccine shots. Post booster on 11/12/2021, she has been experiencing shortness of breath,  chest pain, chest heaviness, headache, cough, headaches, and intermittent diaphoresis. She describes her chest pain as "someone is sitting on top of my chest."
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 3 inch long 1 inch wide raised redness at injection site.  Not itchy painful  when touched with light pressure.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Myalgia, Nausea, Vomiting
Clinical narrative: Patient felt lightheaded after vaccine on 11/14. We gave ice pack and a water bottle and had him sit for a bit. He ultimately decided to leave and go home.   On 11/15 patient called to report to me he has progressively felt more sick. He vomited late last night 11/14 and again this morning 11/15. Now just nausea. Also experiencing muscle aches and pains.
Age: 73.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse events reported.  Patient was given the second dose for the hepatitis A vaccine earlier than indicated (rather than 6-12 months after the first dose which was given on 7/4/2021).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Yeast infection
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Immediate post-injection reaction, Lethargy
Clinical narrative: pt rcvd 2nd dose of Moderna today. She immediately felt dizzy. We had her sit with an ice pack and water bottle and eventually moved her to lie on floor with her feet elevated. Symptoms progressed over the next 30 minutes to include trouble exhaling (not inhaling), hot ears, shaking, pale skin, nausea, lethargy, headache/pounding. Blood pressure was 113/72. Pulse was steady, slightly fast. After 30 minutes she agreed to have us call 911. EMT arrived and assessed patient for a further 20 minutes. She declined transport to ER. She was released by EMT to go home.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pallor, Skin warm, Tremor
Clinical narrative: pt rcvd 2nd dose of Moderna today. She immediately felt dizzy. We had her sit with an ice pack and water bottle and eventually moved her to lie on floor with her feet elevated. Symptoms progressed over the next 30 minutes to include trouble exhaling (not inhaling), hot ears, shaking, pale skin, nausea, lethargy, headache/pounding. Blood pressure was 113/72. Pulse was steady, slightly fast. After 30 minutes she agreed to have us call 911. EMT arrived and assessed patient for a further 20 minutes. She declined transport to ER. She was released by EMT to go home.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: a patient aged 12 was given 1st pfizer dose at clinic
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse events reported.  Patient received their second dose of the hepatis A vaccine earlier than indicated (first dose was given on 8/3/2021, and second dose was administered on 10/14/2021 instead of 6-12 months after the first dose ).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have had really bad tinnitus since the vaccine and it has made my life miserable. Please help!!!
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Nausea
Clinical narrative: Mild fever, nausea, vomiting, fatigue. Also redness, pain and itching around the injection site.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mild fever, nausea, vomiting, fatigue. Also redness, pain and itching around the injection site.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: intermittent left eye twitching. Vaccine was administered in September. Still in November the problem persists.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pharmacy negligently administered an Adult Pfizer Covid-19 vaccine to my son who is 7 years of age and required a  pediatric Pfizer Covid-19 vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pharmacy negligently administered an Adult Pfizer Covid-19 vaccine to my son who is 10 years of age and required the Pfizer Covid-19 vaccine dose.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Insomnia, Mastoiditis, Migraine
Clinical narrative: Insomnia, migraine, followed by mastoiditis and sudden unilateral hearing loss
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray normal, Diaphragmalgia, Dyspnoea, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: Pain in diaphragm within one minute of vaccine, shortly followed by shortness of air. Vision disturbance, numbness in face/neck, tingling in hands, hives on chest/neck area, tachycardia.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Tachycardia, Troponin normal
Clinical narrative: Pain in diaphragm within one minute of vaccine, shortly followed by shortness of air. Vision disturbance, numbness in face/neck, tingling in hands, hives on chest/neck area, tachycardia.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria, Visual impairment
Clinical narrative: Pain in diaphragm within one minute of vaccine, shortly followed by shortness of air. Vision disturbance, numbness in face/neck, tingling in hands, hives on chest/neck area, tachycardia.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Extra dose administered, Heart rate abnormal, Tremor
Clinical narrative: light shaking and quickened heart rate and breath since the following day after booster. i had lightheadness and dizziness immediately.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Presyncope
Clinical narrative: PT RECEIVED VACCINE AND AFTER WAITING 15 MINUTES, PT STOOD TO COME CHECK OUT WITH IMMUNIZATIONS AND VASO VAGEL.  PT HIT HIS HEAD WHEN HE FELL DOWN.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Colitis ischaemic, Colonoscopy abnormal, Computerised tomogram abdomen
Clinical narrative: Ischemic colitis; symptoms 3 weeks after 2nd dose: sudden abdominal pain, bloody diarrhea,  passing blood clots instead of stool;  had blood work & CT at the ER, saw gastroenterologist and had colonoscopy 5 days later. Colonoscopy confirmed ischemic colitis.  No symptoms prior to this. No GI history.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea haemorrhagic, Haematochezia, Haemorrhoids thrombosed, Scan with contrast, Ultrasound abdomen
Clinical narrative: Ischemic colitis; symptoms 3 weeks after 2nd dose: sudden abdominal pain, bloody diarrhea,  passing blood clots instead of stool;  had blood work & CT at the ER, saw gastroenterologist and had colonoscopy 5 days later. Colonoscopy confirmed ischemic colitis.  No symptoms prior to this. No GI history.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: A month-long, heavy menstrual cycle. Never happened before I got the vaccine. Completely abnormal.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Dry skin, Inflammation, Injection site rash, Pruritus
Clinical narrative: Rash still around site of injection.  General dermatitis that is dry, itchy with moderate bumps.  Enflames randomly and is itchier at some times more than others.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Musculoskeletal stiffness, Pain
Clinical narrative: Persistent and severe migraine headaches; heavy pressure in the occipital region and ears; Neck stiffness/ache accompanied by acute pain radiating to the shoulders; Neck stiffness/ache accompanied by acute pain radiating to the shoulders; This is a spontaneous report from a contactable consumer. A 41-years-old non female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8727, dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:30 as dose 1, single for covid-19 immunization. The patient's medical history included diabetes and drug hypersensitivity from an unknown date. Concomitant medications included metformin and insulin detemir taken for an unspecified indication. on an unspecified date, the patient experienced persistent and severe migraine headaches, heavy pressure in the occipital region and ears, neck stiffness/ache accompanied by acute pain radiating to the shoulders and neck stiffness/ache accompanied by acute pain radiating to the shoulders. Patient received treatment for events. The outcome of events was not recovered.No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Mobility decreased, Movement disorder
Clinical narrative: I had fever, chill, fatigue, diarrhea and nausea on 11/10/2021. After 48 hour of my vaccine, the left side of my body became super painful and I was not able to move the left side of my body. I couldn?t lift my arm, turn my head and straighten my back and waist. Those symptom last for 24 hours until 11/12/2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I had fever, chill, fatigue, diarrhea and nausea on 11/10/2021. After 48 hour of my vaccine, the left side of my body became super painful and I was not able to move the left side of my body. I couldn?t lift my arm, turn my head and straighten my back and waist. Those symptom last for 24 hours until 11/12/2021.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Insomnia, Nausea
Clinical narrative: I received my vaccine at 1400 and developed my first symptom of severe joint pain in all my joints at 1600. The symptoms progressed to loud ringing in both ears, sharp headache, swelling feeling in neck and lower face, uncontrollable chills and inability to sleep with nausea.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Tinnitus
Clinical narrative: I received my vaccine at 1400 and developed my first symptom of severe joint pain in all my joints at 1600. The symptoms progressed to loud ringing in both ears, sharp headache, swelling feeling in neck and lower face, uncontrollable chills and inability to sleep with nausea.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Disorientation, Extra dose administered, Pain in extremity, Vision blurred
Clinical narrative: 2 hours after booster shot I got disoriented and also chest pressure next day blurred vision lasted 2 days I took low dose aspirin that stopped the chest pressure so I did not get medical attention . I used eye drops  and they may have helped clear the blurred vision. Did get the usual pain in arm but used heat and massage to remedy that
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Episcleritis
Clinical narrative: Episcleriitis to right eye
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives to chest back of legs.  Itching.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Chills started 9 hours after injection lasted all night long. Tiredness all day the next day. Pounding headache started 9 hours after vaccine and lasted the whole next day. Swollen injection site that is slightly painful and red
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Chills started 9 hours after injection lasted all night long. Tiredness all day the next day. Pounding headache started 9 hours after vaccine and lasted the whole next day. Swollen injection site that is slightly painful and red
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Peripheral swelling
Clinical narrative: Painful lump in left arm armpit
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: At the evening of the vaccination started with high fever of 38.5 Celsius degrees and until end of the next day this went up 3 times to over 40 Celsius degrees with the highest of 40.5 by end of the day first two nights with sweating heavily tried to reduce body heat by Paracetamol, Kalmopyrin, Algopirin with 4 hours difference neither helped, but cooling bath reduced the body temp both in the morning and afternoon by 2 Celsius degrees. Third Day went with 37.2 Celsius degree with and a moderate general headache. The fourth day my body Temperature went back to normal but the headache  got serious at the temple and the eye socket.