chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urinary tract infection
Clinical narrative: A female patient received bnt162b2 (Pfizer- Biontech COVID-19 Vaccine Formulation: Solution for injection), via an unspecified route of administration on 05May2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included eczema ( I have eczema, its since I was a baby) , food allergy, food allergy, drug hypersensitivity and food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced i had an uti on an unspecified date.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date.  I have anaphylactic shock. Penicillin - not sure my reaction, I have eczema, its since I was a baby. I was told I was allergic to it, probably itching because of the eczema, I haven't drank orange juice in a long time, it makes me itchy, that's probably what the reaction to penicillin was.  The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The patient received the first shot of Pfizer COVID-19 vaccine seven weeks ago. However, 10 days after getting the vaccine he got COVID. He had severe symptoms for week and a half but not to the point needed hospitalization. One week later he was clear and received a negative result. HE was clear now still have minor side effects. He did not feel comfortable getting the second dose of the vaccine at that time. He feel good enough to take the Pfizer COVID-19 vaccine but on him 49 day today. The patient asked the question would the vaccine be effective if he receive it 49 days after dose 1 and would it cause any danger to his health if he receive the vaccine this late. He went to get his vaccine, but they had some advisory at the clinic stating the vaccine could not be given later then 42 days after dose 1. The patient received first vaccine and 10 days later tested positive for Covid; symptoms afraid her because slight increased symptoms; it was dangerous, betrayed and it infected him. The patient stated, he had a very specific question to ask about the Pfizer Covid vaccine just for brief describe, he took the 1st dose of vaccine on 17Mar2021 and after 10 days later he tested positive for Covid and since then he thought recovering from Covid but now he betrayed, but symptoms afraid him, slight increases in symptoms when he had ever been want to go back to get his second shot or feel well enough to go back and get his second shot until now. The point was they gave him first shot and second shot was currently 49 days, was second shot still available for him or it was dangerous or it infected or was there another scenario that comes in private for research was there something secret. Patient was informed about Pfizer Medical information Department. Because it was on 10 days after the first dose, the time frame was significant in that probably the first dose had no impact to when that happening had it been three weeks before or 4 weeks before was probably medical value in that for what do or not, because he want to know if he can get the second shot that was more important if give him that number, would like to call that number. The patient underwent lab tests and procedures which included COVID test: positive (after getting the vaccine I got COVID) on 27Mar2021, negative (One week later I was clear and received a negative result) on Apr2021. The outcome of event was recovered on Apr2021.  No follow-up attempts are possible. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous for several days; This is a spontaneous report from a non-contactable pharmacist.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at unknown single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. The patient stated she was nauseous for several days after getting vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: On an unspecified date, approximately 14 hours after the 2nd dose, the patient experienced pain up and down her left side, the side of the shot. The next day, the patient had a migraine when standing up. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: He received the first dose of the covid 19 vaccine noted body aches improved; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. The first report is a report received by Pfizer . A 53-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient's medical history included hypertension from 2011 and body aches. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and noted body aches improved on an unspecified date.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same patient, diff drug/event
Sex: U
Vaccine: COVID19
Symptoms: Cerebral disorder, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: Feeling bad; My brain feels like it's going totally different way; Nauseous; Headache/sometimes during my headache I have my head hurts; Tired all the time; I am not well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 29Apr2021 (Thursday) as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient was feeling bad since 29Apr2021 (late Thursday) evening and was just curious to know how long that these symptoms can go on because the patient had to go back to work the next day (30Apr2021). The patient was feeling a little nauseous and had a headache while sometimes during headache, the head hurts on an unspecified date in 2021. The patient was tired all the time and the brain feels like it's going totally different way on an unspecified date in 2021. The outcome of these events was unknown at the reporting time.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Feeling bad; My brain feels like it's going totally different way; Nauseous; Headache/sometimes during my headache I have my head hurts; Tired all the time; I am not well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 29Apr2021 (Thursday) as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient was feeling bad since 29Apr2021 (late Thursday) evening and was just curious to know how long that these symptoms can go on because the patient had to go back to work the next day (30Apr2021). The patient was feeling a little nauseous and had a headache while sometimes during headache, the head hurts on an unspecified date in 2021. The patient was tired all the time and the brain feels like it's going totally different way on an unspecified date in 2021. The outcome of these events was unknown at the reporting time.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Got a bad cough and each day is getting worse, as far as the coughing; Not a high fever but a 99.8 fever; Oxygen between 93 and 94; Very weak; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in arm on 26Apr2021 (Monday), 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date, 1st dose, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced a bad cough and he was very weak. The reporter stated that each day was getting worse, as far as the coughing. The patient did not have a high fever but had a 99.8 fever. It was reported that the patient put the oxygen thing on his finger, and it flicked between 93 and 94. The reporter asked whether she should bring the patient to the emergency room, or minute clinic and was advised to contact health care provider if she thought it was necessary. The outcome of the event got a bad cough and each day was getting worse, as far as the coughing was not recovered. Outcome of other events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Got a bad cough and each day is getting worse, as far as the coughing; Not a high fever but a 99.8 fever; Oxygen between 93 and 94; Very weak; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in arm on 26Apr2021 (Monday), 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date, 1st dose, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced a bad cough and he was very weak. The reporter stated that each day was getting worse, as far as the coughing. The patient did not have a high fever but had a 99.8 fever. It was reported that the patient put the oxygen thing on his finger, and it flicked between 93 and 94. The reporter asked whether she should bring the patient to the emergency room, or minute clinic and was advised to contact health care provider if she thought it was necessary. The outcome of the event got a bad cough and each day was getting worse, as far as the coughing was not recovered. Outcome of other events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient went to get the shot on 26Apr2021 and on 28Apr2021 he was diagnosed with COVID. They wanted to know if they need to get the second shot or delay it. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lacrimation increased, Pain, Pyrexia, Rhinorrhoea, Throat irritation
Clinical narrative: Pain kind of hurt; Watery Nose; I came down with Fever; Watery eyes; Burning throat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Apr2021 (Lot Number: SW0172) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and the concomitant medications were not reported. On 30Apr2021, the patient came down with a fever and watery eyes, burning throat and just had sinus passageway and then on 01May2021, patient woke up with a fever again and had the pain kind of hurt, and still had fever and watery nose the whole day.That's all the problem patient had. The patient asked whether he/she should get a COVID test or it was normal. The outcome was reported as not recovered for fever and runny nose and unknown for rest of the events at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fear of falling, Illness, Pyrexia
Clinical narrative: Dizzy after the first dose of the vaccine; Felt very sick/Sick as a dog; 102 degree fever after first dose of the vaccine; He felt dizzy and thought he was going to fall over; This is a spontaneous report from a contactable consumer (patient).  A 52-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732 ), at single dose via an unspecified route of administration on 29Mar2021 for covid-19 immunization (at the age of 52 years). Medical history included ongoing asthma (had for 20-30 years), diabetes (from 2018 and ongoing but on and off since 2018), covid-19 from Jan2021 to an unknown date (No Investigation Assessment), motor vehicle accident he had in 2002- took Naprosyn and it helped. States that before all of this he had lost (weight) pounds and been eating very well. The patient's concomitant medications were not reported. Previously, the patient had flu vaccine and he got the flu every time he got it (Vaccination Date: 2002 or 2003). No other products. After the first dose of the vaccine, on 29Mar2021 he had a 102degree fever a few minutes after the shot and was dizzy. He felt dizzy and thought he was going to fall over on an unspecified date in Mar2021. On 29Mar2021 he felt very sick; dizzy after first dose of the covid vaccine and stated that he sat for a bit after his shot. Paramedics there who took his temperature and that it was 101 point something; close to 102. They told him to go home and relax and take Tylenol. States he went home and took Aleve as therapeutic measure and felt better. It lasted one more day then went away. The patient underwent lab tests and procedures which included body temperature: 102 on 29Mar2021 it was 101 point something; close to 102. Rest relevant tests were none. The Outcome for fever, dizzy and felt sick was recovered on 30Mar2021; for going to fall over was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Illness, Nasopharyngitis, Pyrexia
Clinical narrative: The patient's medical history and concomitant medications were not reported. The patient reported that she was sick everyday after she took the first dose and experienced all of the symptoms like colds, fever, chills and diarrhea. The outcome of the events was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Defaecation urgency
Clinical narrative: she started to feel abdominal cramps; She had the urge to go to the bathroom but the stool is described as formed; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot number and expiration date were not reported), via an unspecified route of administration on 30Apr2021 at 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient started to feel abdominal cramps on 02May2021 and then it became horrendous. She described the abdominal cramps like diarrhea. She had the urge to go to the bathroom but the stool is described as formed (not watery) on 02May2021. She wanted to know if this was because of the virus or a side effect from the shot. The outcome of the events was unknown. She stated that next vaccine dose was scheduled on 29May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Positron emission tomogram
Clinical narrative: The patient medical history and concomitant medications were not reported. On Feb2021 the patient experienced went for a pet scan and they noted that she has an increased large node under her left arm and swollen lymph. The patient underwent lab tests and procedures which included positron emission tomogram: unknown on they noted that she has an increased large node under her left arm. The outcome of event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 09Apr2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer COVID Vaccine on 09Apr2021. On 21Apr2021 she tested positive for COVID and was not able to receive her scheduled second dose. She was asking if it would be okay for her to receive her second dose if the 3 weeks have already passed. The patient underwent lab tests and procedures which included test for COVID: positive on 21Apr2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: The patient's medical history and concomitant medications were not reported. The patient experienced cold on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from non-contactable consumer from a Pfizer sponsored program. This consumer reported similar events for four patients. This is one of the four reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cold on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :  same reporter, drug, event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: He is cleared of Covid now but he missed his second dose 16Apr2021; A week later he ended up getting Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced a week later he ended up getting covid. On 16Apr2021, the patient experienced he is cleared of covid now but he missed his second dose 16Apr2021. Caller got his first dose of the vaccine last 26Mar2021. A week later he ended up getting Covid. He is cleared of Covid now but he missed his second dose schedule last 16Apr2021. He called in to know the protocol to take or if he can still get the second dose of the vaccine. The patient did not receive any treatment for the events. The clinical outcomes of the a week later he ended up getting Covid was recovered and of the he is cleared of Covid now but he missed his second dose 16Apr2021 was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test
Clinical narrative: flu like symptoms; positive COVID test; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (solution for injection) via an unspecified route of administration on 23Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date it was reported that patient received first dose of vaccine on 23Apr2021. Wednesday patient started feeling flu like symptoms. 01May2021 patient received a positive COVID test. Second dose is scheduled for 14May2021. Patient would like to know if she can still get second dose of vaccine. Patient didn't receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: who was pre-period, had 2 periods in less than a month; This is a spontaneous report from a contactable consumer. An 11-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medications were not reported. The patient who was pre-period, had 2 periods in less than a month on an unspecified date. Reporter was asking if it would be possible to transmit the spike protein that the body generates after vaccination via shedding like skin contact and inhalation. Reporter stated that he did not state that the girl or family died. He stated that he does not know whether the girl or family died but that the dog died. He stated that the 11 year old girl, who was pre-period, had 2 periods in less than a month after being exposed to her vaccinated mother. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site pain
Clinical narrative: Injection site hurts; arm feels like black and blue but its not; This is a spontaneous report received from contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on 04May2021, 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, after she received her first dose, her arm felt like black and blue but it is not (as reported) and injection site hurts a little. The provider asked the patient when she wanted to receive the second dose and the patient picked 19May2021 (2 weeks). The patient read the fact sheet that the facility gave her after receiving the 1st dose and she had read that the 2nd dose should be given 3 weeks after the 1st dose hence the patient rescheduled her second dose. The outcome of the events was not recovered.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: tested positive the week after; sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's daughter) reported that a 69-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 vaccine, solution for injection) via an unspecified route of administration on 14Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date it was reported that patient got the first shot on 14Apr2021 and tested positive the week after. They got COVID and have been sick for 2 weeks. patient was now getting out from the disease, patient would like to know the appropriate amount of time when to receive the second dose. The outcome of COVID-19 (PT) was recovering while for other event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Feeling cold, Feeling hot, Increased tendency to bruise
Clinical narrative: dizzy spell; Spinning feeling of heat from her feet to her head; stomach pains/stomach hurts when eating; stomach muscle spasms; possible weight gain; feels cold all the time; easy bruising; This is a spontaneous report from a non-contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included car accident in November in hospital for 2 days. The patient's concomitant medication included nilotinib hydrochloride (TASIGNA) ate food after it one day. The patient experienced dizzy spell, felt like spinning feeling of heat from her feet to her head day after COVID vaccine on an unspecified date. The patient had stomach pain/stomach hurts when eating and stomach muscle spasms, possible weight gain, feels cold all the time and easy bruising on an unspecified date. The outcome was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Weight increased
Clinical narrative: dizzy spell; Spinning feeling of heat from her feet to her head; stomach pains/stomach hurts when eating; stomach muscle spasms; possible weight gain; feels cold all the time; easy bruising; This is a spontaneous report from a non-contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included car accident in November in hospital for 2 days. The patient's concomitant medication included nilotinib hydrochloride (TASIGNA) ate food after it one day. The patient experienced dizzy spell, felt like spinning feeling of heat from her feet to her head day after COVID vaccine on an unspecified date. The patient had stomach pain/stomach hurts when eating and stomach muscle spasms, possible weight gain, feels cold all the time and easy bruising on an unspecified date. The outcome was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Not feeling well; fatigued; This is a spontaneous report from a contactable consumer (who reported for herself) . A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number EW0150) on 30Mar2021 at 11:30 AM, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization, in left arm. 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. Medical history was not reported. The patient had no known allergies. Concomitant medications included: Birth control. On 03Mar2021 at 05:00 PM, the patient experienced she was "not feeling well" she means that she was fatigued and beat all the time. Reporter stated this event started within the first 24 hours of being administered the first dose but that now she is almost 100% recovered from feeling fatigued and feeling beat. The clinical outcome of the events was recovered.  Since the vaccination, the patient has not been tested for COVID-19.   Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Caller states that she got her 2nd dose of the COVID vaccine, and is wanting to know if it causes a UTI; This is a spontaneous report received from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (batch/lot number unknown) via an unspecified route of administration on an unknown date at 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that she got her 2nd dose of the COVID vaccine, and was wanting to know if it caused a UTI. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Electrocardiogram, Lymphadenopathy, Musculoskeletal discomfort
Clinical narrative: mild discomfort on the left side in her neck and middle of her chest after first vaccine; mild discomfort on the left side in her neck and middle of her chest after first vaccine; she thinks are swollen lymph nodes were on the left side; This is a spontaneous report from a contactable consumer or other non hcp (patient).    A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration in the right arm on 03Mar2021 between 11 and 11:30 am, at 70 years old, as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HYDROCHLOROTHIAZIDE KRKA) taken for hypertension, start and stop date were not reported. The patient previously took influenza vaccine in Oct2020 for immunisation. The patient experienced mild discomfort on the left side in her neck and middle of her chest after first vaccine and she thinks are swollen lymph nodes were on the left side on an unspecified date with outcome of recovering. The patient was seen in emergency room and underwent EKG and chest X-ray on unspecified date, tests were fine in terms of cardiac and they did not admit her. The patient reported that the left side discomfort was not completely gone but it is really mild now.  No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021475398 Same patient and drug, different event (2nd dose case)
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: significant headache; tested positive of COVID-19; This is a spontaneous report from a contactable consumer (physician Assistant) reporting for her husband.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as single dose at an unknown age for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was tested positive of COVID-19 in Apr2021 after vaccination, significant headache on 22Apr2021. The event tested positive of COVID-19 was considered medically significant. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive in Apr2021, his test results (both rapid and PCR) confirmed positive. The course of events was as follows: her husband received his first dose of the Pfizer vaccine Thursday 22Apr2021 and developed a significant headache. Friday a.m. 23Apr2021 as he still had a headache the reporter asked for him to get a screening COVID test to make sure it was only a response to the vaccine and not something more serious. They were very surprised when his test results (both rapid and PCR) confirmed positive. The outcome of events was unknown.  Information about the Lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Muscular weakness
Clinical narrative: leg weakness became worse; This is a spontaneous report received from a contactable consumer. This is the second of 2 reports. A 71-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) via an unspecified route of administration in right arm on 19Feb2021 at age of 71-year-old at single dose for COVID-19 immunisation. Relevant medical history included COVID-19 from Nov2020 (Was in hospital with COVID in November. Did well in December and January). Other medical history reported as "none". No known allergies. Concomitant medications (received within 2 weeks of vaccination) included bupropion taken for an unspecified indication from an unspecified date; clonazepam taken for an unspecified indication from an unspecified date and "Celebs" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9262) via an unspecified route of administration in left arm on 30Jan2021 at age of 71-year-old at single dose for COVID-19 immunisation and experienced "after first shot began experiencing weakness in legs" and "fell several times" on 01Feb2021. It reported after second shot leg weakness became worse. The event onset date after second shot was not reported. "Steroids" was considered as treatment for the event. CT scans of entire spine and brain with unknown result. The event resulted in Doctor or other healthcare professional office/clinic visit, Hospitalization (for 23 days), Disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476453 same patient/reporter/drug, different AE in separated time
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of IPOL was inadvertently administered/No AE; Initial information regarding an unsolicited valid non-serious case was received on 26-Apr-2021 from a health care professional  This case involves a 13 year-old female patient who was inadvertently vaccinated with expired dose of IPV (VERO) [IPOL] (Expired product administered).   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE for prophylactic vaccination.  On 26-Apr-2021, the patient received third dose of suspect IPV (VERO) (Strength: standard; lot R1B251M and expiry date 13-Mar-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was also reported that "caller with question on whether dose needed repetition. Caller also with question on any safety concern with administering expired dose".  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A patient received Adacel vaccine 2 weeks apart from one another, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (MI) (Reference number- 00581018) and transmitted to Sanofi on 28-Apr-2021.  This case involves a patient (unknown demographics) who received two doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6628AA, expiry date: 04-Apr-2022 and lot U6767AA and expiry date: 31-Jul-2022) via an unknown route in an unknown administration site for prophylactic vaccination 2 weeks apart from one another on an unknown date (inappropriate schedule of product administration).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to drug dose administration interval too short (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUA3
Symptoms: Fatigue
Clinical narrative: The vaccine he received has made him very fatigued; This is a spontaneous case from the, initially received from other non-health professional via The Agency (reference number: SEQW20-00216) on 30-Mar-2020, concerning a male patient of unknown age.  The patient's current condition and concomitant medications were not provided.  On unknown date, the patient was administered Fluad TIV [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number, expiration date, route of administration, dose and anatomical location: not reported] for unknown indication.  On unknown date, unknown amount of time after vaccination, the patient was very fatigued.  At the time of this report, the outcome for the event of 'fatigue' was not reported.  The case was assessed as non-serious.  The reporter stated the vaccine made him very fatigued.  Company comment: The event of 'fatigue' is considered related to Fluad TIV.; Reporter's Comments: The reporter stated the vaccine made him very fatigued.; Sender's Comments: The event of 'fatigue' is considered as related to Fluad TIV.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysphonia, Swelling face
Clinical narrative: Hoarseness in voice; Muscles in her face were swollen; This is a spontaneous case from the , initially reported by other non-health professional to The Agency (reference number: SEQW20-00288) on 13-Apr-2020, concerning a 46-year-old female patient.   The patient medical history and concomitant medications were not reported.  On 30-Mar-2020, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] for influenza prophylaxis.  On an unspecified date in 2020, unknown time after vaccination, muscles in the patient's face were swollen and she had hoarseness in her voice.  At the time of initial report, the outcome of all events was unknown.  The case was assessed as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient developed dysphonia and swelling face unknown amount of time after vaccination with Flucelvax QIV. Chronology needs more clarification. The patient medical history and concomitant medications were not reported. With information available, causal role of the suspect product is assessed as possibly related.; Sender's Comments: The patient developed dysphonia and swelling face unknown amount of time after vaccination with Flucelvax QIV. Chronology needs more clarification. The patient medical history and concomitant medications were not reported. With information available, causal role of the suspect product is assessed as possibly related.
Sex: U
Vaccine: FLUC4
Symptoms: Vaccination site mass, Vaccination site rash
Clinical narrative: A bump at the site of administration of the vaccine; A 3 inch rash at the site of administration of the vaccine; This spontaneous case from  was received on 24-Sep-2020 from other non-health professional via The Agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849, expiry date: 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked with cases: 202004696, 202004698, 202004699, 202004706, 202004701, 202004702, 202004703, 202004704, 202004705, 202004678, and 202004700 (same reporter).  Additional non-significant information received on 06-Jan-2021 from other non-health professional via The Agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional (reference number: SEQW21-00149) (being processed together): Two additional reporters added. Reference numbers added. No changes in narrative.  Company comment: The patient developed vaccination site mass and vaccination site rash on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Considering all information above, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site mass and vaccination site rash on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Considering all information above, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Sex: U
Vaccine: FLUC4
Symptoms: Injection site mass, Injection site rash
Clinical narrative: A bump and a 3 inch rash at the site of administration of the vaccine; A bump and a 3 inch rash at the site of administration of the vaccine; This spontaneous case from the was received on 24-Sep-2020 from other non-health professional via The Agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849 and expiry date was 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine. The patient did not receive any corrective treatment for the events.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked to cases 202004678, 202004696, 202004697, 202004699, 202004700, 202004701, 202004702, 202004703, 202004704, 202004705 and 202004706, due to the same reporter.  Additional non-significant information received on 06-Jan-2021 from other non-health professional via The Agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional (reference number: SEQW21-00149) (being processed together): Two reporters were added. Reference numbers added. No changes in narrative.  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.