chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hyperacusis, Hypertension, Migraine, Photophobia
Clinical narrative: Migraines; Sensitivity to sound; Higher blood pressure; Sensitivity to light; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), first dose on 25Mar2021 08:00 (Lot number: EP7534) and second dose on 15Apr2021 (Lot number: ER8737) both via an unspecified route of administration, administered in right arm as single dose for COVID-19 immunisation. Medical history included RSV (respiratory syncytial virus) autoimmune. No Prior Vaccinations (within 4 weeks). Concomitant medications included ongoing lisinopril (Has been taking for years). It was reported that she was still dealing with migraines and everything else, and light sensitivity. Migraines started the day after the second dose on 16Apr2021, and she had it for 6 days straight. It settled some, enough for her to think straight. It was back again yesterday and was full fledge today. Has had to wear sunglasses ever since. Treatment: Imitrex and some Toradol. She had higher blood pressure in the beginning when she got the first shot in 2021. They gave her another blood pressure medication, stated that the blood pressure was better now. Sensitivity to light it was explained that this was lasting longer than the migraines; she was back in sunglasses due to this in 2021. She also has some sound sensitivity but that was part of the migraines. She has had this going on since the migraines started in Apr2021. Due to migraines patient visited Emergency Room the other month when this first started, in Apr2021. Was not admitted to the hospital. Was on 12 different medications in the previous year. Clarified that she was not on any other medications within 2 weeks prior to the Covid 19 vaccine. The outcome of event migraine was not recovered, blood pressure high was recovering, remaining events were unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: I was sick for like about 24 hours; I have been getting headaches slightly; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EW0176), via an unspecified route of administration on an unspecified date (on Tuesday) in 2021, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. On an unspecified date in 2021, after the vaccination, the patient was sick and experienced headache. The clinical course of the event as follows: the patient got the second dose of the Pfizer vaccine (Unspecified vaccine) on Tuesday and she was sick for like about 24 hours and then I felt fine, but she had been getting headaches slightly since then. The patient was wondering whether it was normal side effect or not. The events were reported as non-serious. On an unspecified date in 2021, the patient was resolved from the sickness. The outcome of the other event was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Arm hurt; This is a spontaneous report received from a non-contactable consumer. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jan2021 as unknown, single dose for COVID-19 immunisation (Age at the time of vaccination 13-year-old). The patient medical history and concomitant medications were not reported. It was reported that, the patient had COVID shot on 03Jan2021, on the next day (04Jan2021) patient arm hurt with headache. Cleared by next day. The outcome of events was recovered on 05Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever; Not feeling well; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/Lot number: EW0183), via an unspecified route of administration on 04Jun2021 as 2nd dose, single dose  for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Jun2021, the patient experienced fever and not feeling well. It was reported that consumer stated "I actually got my second Pfizer dose yesterday (04Jun2021) and I was having some fever so, I wanted to know can I take Tylenol or Advil or there was any preferred medicine which I need to take to reduce the fever." The outcome of both events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Fatigue; Dizziness; This is a spontaneous report from a Non-contactable pharmacist. This pharmacist reported that a 12-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 03Jun2021, as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date, as single dose for Covid-19 immunization. On 04Jun2021, the patient complained of fatigue and dizziness. 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: Malaise, Weight decreased
Clinical narrative: lost weight; having all kinds of physical problems; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration on 01Mar2021 as 1ST DOSE, SINGLE DOSE and via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot Number: not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient lost weight, body had changed and was having all kinds of physical problems ever since vaccine was received on 01Mar2021. The patient have these events from both the shots. Outcome of the events was unknown.  Information on the lot/batch, further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: I had the pain under the bottom of my left foot like fire that would not go out, that pain was so unbearable; I could not walk, the bottom of foot was swollen; I could not walk, the bottom of foot was swollen; Weakness; My mind went blank I couldn't remember something I do all the time I just went blank; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration in deltoid right on 24May202 (Batch/Lot Number: EW0187; Expiration Date: unknown) (at the age of 48-year-old) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date in the year 2020 to an unknown date in the year 2020. The patient's concomitant medications were not reported. The patient reported that she got the vaccine on the 24May2021 (Monday), by the 24May2021 (Monday night) "i had the pain under the bottom of my left foot like fire that would not go out, that pain was so unbearable" and that was the very same pain she had when she got the COVID the last year (2020), she had to be on round the clock medicine she could not walk, the bottom of foot was swollen just like she had the COVID last year, and there was a weakness. When I called to the doctor, the pain she was in, the doctor wanted her to go to the emergency room but she could not go to the emergency room it was so bad. When there was the weakness, she was so weak she just felt better this past Sunday (30May2021), that's how many stage it took me to come back to herself. The patient reported when the very day she got the vaccine she was at work and my mind went blank I couldn't remember something I do all the time I just went blank" and I could not remember. It was just that one shot to space the time and she was struggling couple of days after there was some struggle just remembering things all of that scary enough, but it was very concerning to the point where I could not want to take the second vaccine, that's how scary the whole experience for her. The outcome of the events was unknown.  Was requested for additional information
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Experienced itchy rash on torso and back (quarter sized circles) within a day or two of receiving second dose of vaccine; This is a Marketing Program spontaneous report from a non-contactable consumer or other non hcp (Patient) via a sales representative. A 21-year-old female patient received the 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 an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced Itchy rash on torso and back (quarter sized circles) within a day or two of receiving second dose of vaccine. The clinical outcome for the event was unknown. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle disorder, Nerve injury
Clinical narrative: Permanent disfigurement of my muscles; it's like my arm is sunken where they gave me the shot; permanent disfigurement of her 'nerve' and her muscles; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 59-years-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot Number: EL1284; Expiration Date: Apr2021), via intramuscular route of administration in left arm on 27Jan2021 (vaccination at the age of 59-year-old) as unknown, single dose for covid-19 immunisation. Medical history included allergy from an unknown date and unknown if ongoing. Concomitantly patient was taking allergy pills (Singulair, I think I do not know). Patient had not received any other vaccination within 4weeks. On 27Jan2021, almost immediately same day, the patient experienced permanent disfigurement of her muscles, it was like her arm was sunken where they gave her the shot. Patient reported that she got vaccine in Jan2021 and had permanent disfigurement of her 'nerve' and her muscles. Patient asked if it was part of side effect and had it happened to anyone else. No treatment was taken for the event, as patient stated that nobody knows what it was. They had not seen this before. Reporter seriousness was unspecified. No investigation assessment was done. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache; Arm was a little sore; Low-grade temperature; This is a spontaneous report from a contactable consumer reported for herself. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in left arm on 08May2021 08:00 (Batch/Lot Number: ER8736) as a single dose for covid-19 immunisation at School or Student Health Clinic. Medical history included congestive cardiac failure, coronary artery disease, hypertension, asthma, migraines, narcolepsy, bipolar disorder, sleep apnoea, gastrooesophageal reflux disease, low potassium, low iron, tomatoes allergy, dust allergy, pollen allergy, grass allergy, ragweed allergy, allergy to medications included morphine allergy and ceclor allergy. Concomitant medications included carvedilol (COREG), clopidogrel bisulfate (PLAVIX), omega-3-acid ethyl ester (LOVAZA), bepotastine besilate (POTAS), furosemide (LASIX [FUROSEMIDE]), atorvastatin calcium and ezetimibe (STATIN EZ).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 and Since the vaccination, the patient has not been been tested for COVID-19. The patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 05Jun2021 09:45 (Batch/Lot Number: EW0179) as a single dose for covid-19 immunisation.On 08May2021, 08:00 after administration of first dose of vaccine the patient experienced arm was a little sore, low grade temperature and headache too for some days. Clinical course was reported as on the first shot my arm was a little sore, I got a low-grade temperature and a headache too for a few days. However, with all of my allergies to medication, etc this vaccine did not bother me at all in that regard.The patient underwent lab tests and procedures which included body temperature was low. There was no treatment given for the reported events. Outcome of the events arm was a little sore, low grade temperature and headache was recovered on an unspecified date in 2021..
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Off label use, Vaccination site haemorrhage
Clinical narrative: daughter had a blood after the vaccine was administered; daughter had a blood after the vaccine was administered; daughter had a blood after the vaccine was administered; This is a spontaneous report from contactable consumer (patient father) from a Pfizer sponsored program .  A 14-year-old female patient received first dose of bnt162b2 (PFIZER COVID 19 VACCINE, Solution for Injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date at a 1st dose, single dose; patient received second dose of bnt162b2 (PFIZER COVID 19 VACCINE, Solution for Injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date at a 2nd dose, single dose, both doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced daughter had a blood after the vaccine was administered on an unspecified date. Reporter called for his 14 year old daughter who got the second dose of the vaccine (Unspecified Medication) yesterday, now he said that when it was administered, the one who administered the vaccine said that he hit a blood vessel and his daughter had a blood after the vaccine was administered (on an unspecified date). The reporter had a question whether they need to watch out for others signs or side effects that might arise since a blood vessel that was hit when the vaccine was administered and if there was something that they need to concerned with. Reporter stated patient was not really having any major side effects right now. Reporter just had a question whether they should be concerned for having hit the blood vessel. Outcome of the events was unknown.  Information about Lot Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Platelet count decreased
Clinical narrative: He got his blood work with low platelets; first one was low and the second one was even lower; This is a spontaneous report received from a contactable consumer or other non-health professional (patient wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, patient got his blood work with low platelets. Reporter stated that she was concerned for patient as for the second time since he had the vaccine which was in January. Patient got his blood work with low platelets. The first one was low and the second one was even lower. Reporter was reading about some concerns and people quaking with same issues even people dying from this. So, reporter wanted to know how many people do you like have reporting this issue and what was the best way to approach this and what Pfizer can do because this was the first time that patient had this problem.Reporter stated that was her suspicion because after speaking to several physicians. They told that patient was not the only case. They have seen people with the side effect reaction. Reporter was wondering tomorrow her son 12 years old was going to get the second shot, so reporter was really concerned what was happening, she asked could you tell me what was happening with this situation specifically with the Pfizer vaccine from any people are you getting this issue. The patient underwent lab tests and procedures which included blood test: with low platelets. The report was not related to study or programme. The outcome of the event was unknown  Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Lethargy, Pyrexia
Clinical narrative: Sweaty; Threw up; Lethargic; Fever; Chills; This is a spontaneous report from a contactable consumer (parent). A 12-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date: unknown), via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration on unspecified date for COVID-19 immunization. On 05Jun2021, the patient received the vaccine in the morning and developed a fever and had chills. The patient was given Tylenol before bed around 21:00 and he woke up sweaty and threw up around 03:30 (on 06Jun2021). The patient went back to bed and woke up Sunday (06Jun2021) with a fever of 100.2 and was lethargic but in good spirits. The patient underwent lab tests and procedures which included body temperature: 100.2 on 06Jun2021. Therapeutic measures were taken as a result of fever and chills. The outcome of the events was unknown.  Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sweaty; Threw up; Lethargic; Fever; Chills; This is a spontaneous report from a contactable consumer (parent). A 12-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date: unknown), via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration on unspecified date for COVID-19 immunization. On 05Jun2021, the patient received the vaccine in the morning and developed a fever and had chills. The patient was given Tylenol before bed around 21:00 and he woke up sweaty and threw up around 03:30 (on 06Jun2021). The patient went back to bed and woke up Sunday (06Jun2021) with a fever of 100.2 and was lethargic but in good spirits. The patient underwent lab tests and procedures which included body temperature: 100.2 on 06Jun2021. Therapeutic measures were taken as a result of fever and chills. The outcome of the events was unknown.  Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever like 101.44; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 13-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0178, Expiration date: unknown), via an unspecified route of administration, administered in left arm on 03Jun2021 as 2nd dose, single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. He was a healthy kid before vaccination. Patient received dose 1 of bnt162b2 on 13May2021 for Covid-19 immunization and experienced mild side effects. On 03Jun2021 the patient experienced fever like 101.44. He started running fever after second dose of vaccine. The patient underwent lab tests which included body temperature 101.44 on Jun2021. Therapeutic measures were taken as a result of fever like 101.44 includes Its going down with Ibuprofen and Acetaminophen that seemed to get under control, but it kept coming back and the reporter just didn't know that was something normal that she should expect. Reporter was just curious that her 13-year-old got his second dose of Pfizer on 03Jun2021, so its 06Jun2021 and he was still running a fever like 101.4. The outcome of fever was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for the past month after receiving 2nd vaccine on May 4, 2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0175) via an unspecified route of administration on 04May2021 (at the age of 52-year-old) as a single dose for COVID-19 immunization. The patient had no medical history and known allergies. Concomitant medications were not reported. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0161) via an unspecified route of administration in left arm on 13Apr2021 as a single dose for COVID-19 immunization and experienced mensural cycles again after 5 months into menopause. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021, the patient experienced diarrhea for the past month after receiving the second vaccine. The patient did not receive any treatment for the event. The outcome of event was not recovered.  Follow up attempts needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Platelet count, Platelet count decreased, Red blood cell count, Red blood cell count decreased
Clinical narrative: got his blood work with low platelets, first one and second one was even lower/blood platelets very low; got his blood work with low platelets, first one and second one was even lower/blood platelets very low; blood RBCs and blood platelets very low; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an un-specified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an un-specified route of administration in Jan2021 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In 2021, patient got his blood work done which showed low blood red blood cells count (RBCs) and very low blood platelets. The first one was low but the second one was even lower for platelets. Patient's wife stated that she understood that this was an issue but could lead to fatality because the platelets were not working properly and if patient found an injury he could be at risk. The outcome of all the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Platelet count decreased
Clinical narrative: I am having a same concern with my father-in-law he got period is very heavy/So I have 2 members in my family with same situation.; This is a spontaneous report received from a contactable consumer or other non-health professional (patient daughter-in-law). A male patient of an unspecified age 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 unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her father-in-law got period is very heavy. So, she has 2 members in her family with same situation. Reporter was wondering tomorrow her son 12 years old was going to get the second shot, so reporter was really concerned what was happening, she asked could you tell me what was happening with this situation specifically with the Pfizer vaccine from any people are you getting this issue. The patient underwent lab tests and procedures which included blood test: with low platelets. The report was not related to study or programme. The outcome of the events was unknown  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pruritus, Pyrexia, Swelling
Clinical narrative: Had a little temperature; Under her shoulder, arm as her whole arm, the bottom of her shoulder it's just swollen/Like the under pit and a little bit down there; Itchy; This is a spontaneous report from a consumer (patient's daughter) reported for the patient. A 82-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 02Jun2021 (age at vaccination was 82 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The reporter stated that her mom got her Pfizer vaccine shot (unspecified vaccine) the second one on 02Jun2021 and she was fine maybe had a little temperature but now she saw under her shoulder, arm as her whole arm, the bottom of her shoulder it's just swollen, asked if that was normal. Like the under pit and a little bit down there. This was the same site she got a needle. It was little itchy too. The reporter was informed about Pfizer Medical information department and was provided with the number. The reporter was informed for the role of Pfizer drug safety. The reporter stated that last night, she noticed it. She didn't know he just checked today but last night it started. Last night, she found out she didn't know if it was like maybe after and she noticed it now. The reporter stated that she just really needed to call to see if she gets the info, they were almost done. The outcome of the events was unknown.  Follow attempts are needed; information about lot number/batch number can be requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyskinesia, Insomnia
Clinical narrative: Not been able to sleep, started insomnia; he try to go to sleep and within an hour or 2 hours his body jerks and wake him back up; Not been able to sleep, started insomnia; he try to go to sleep and within an hour or 2 hours his body jerks and wake him back up; Started developing a cough; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03May2021, as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03May2021, right after his first vaccine, the patient started to have a cough. As time went on, the patient was not able to sleep and started insomnia. Patient tried to sleep and within an hour or 2 hours, his body started to jerk and woke him up. Patient never experienced this before. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: I experienced a pain like somebody has punched me it went away but then it returned; continues to be sore. I've got limited motion and being able to reach back with it; the pain is almost constant; I experienced a pain like somebody has punched me it went away but then it returned; continues to be sore. I've got limited motion and being able to reach back with it; the pain is almost constant; This is a spontaneous report from a contactable consumer (patient, self-reported). A 75-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EWD150 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 28Apr2021 at 13:15, as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 13:15, as a single dose for COVID-19 immunization and it was in his left arm and he experienced a pain like somebody has punched him, it went away but then it returned. Prior Vaccination (4 weeks prior) the patient did not receive any vaccine. The last vaccine he received was for shingles and that was a 2-part vaccine but it was too away at least a couple of months before receiving the vaccine. The patient's medical history included blood pressure and blood cholesterol. Concomitant medications included atorvastatin calcium (the tablet was 20mg and he only took half so that would be 10 mg and that was my cholesterol) and lisinopril. The patient reported that on an unspecified date, he experienced a pain like somebody had punched him, it went away but then it returned; continues to be sore. He had got limited motion and being able to reach back with it; the pain was almost constant and its beginning to worry. When paraphrased, the patient stated, he wanna report that, it happened because that arm was fine, he had no problem with that with his left arm on and he expected soreness to go away and it started getting the limited motion and really pain really increases anytime he moved it towards his back. The patient stated, he had an appointment with his doctor, and they required him to have a lab work done and he was looking at his report, the lab was on 21Apr2021. The patient stated, he saw his doctor about a week later and he told him about it, and he said when he had his injection his arm was very sore and felt like its gonna fall off. He said just continue to stay active and that's what he had done but it's been over a month now and it's not getting better. It felt worst. He was having a hard time sleeping. He got his lab report, and he was sure they could pass you on to where you need to got its a bog facility. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Dyskinesia, Insomnia, Investigation
Clinical narrative: Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable consumer. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on 03May2021 (at the age of 40 years) and second dose of BNT162B2 on 26May2021, as a single dose for COVID-19 immunization. The patient medical history included Ventricular tachycardia and concomitant medications included Amiodarone used for Ventricular tachycardia on an unknown date. Reporter stated that he took the highest dose in that medicine, yes the highest, I do not know what the highest is that he is taking I know it is the highest since they said they cannot give him anything now". Reporter stated, "My son might be having a reaction to the Pfizer vaccine and he has a test in the morning, but he already been into the emergency room and all these and I need to ask or talk to somebody that can medically give me some advice before his test specifically we do not know he can actually have this test now. Reporter added, "Now do you need to know his side effects that he is having from the vaccine that came from the vaccine. Okay the side effects he is having started right after his first vaccine on 03May2021 he started getting the sleep apnea well not sleep apnea sorry about that he started getting insomnia and he cannot sleep and he ended up getting a cough so when he went back to his second vaccine his insomnia started getting worse, he is like he cannot sleep at all and when he does fall asleep its only for 2 hours and he gets so tried, his body start jerking and makes him wake up. Report-er stated, "They are worsening". The patient underwent laboratory test and procedures which included chest X-ray, Nuclear test on Friday and have not got results for that test. Outcome of events was reported as unknown.  Reporter seriousness for Insomnia, Cough, his body start jerking was unspecified.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: He said when he had his injection his arm is very sore and felt like its gonna fall off; He said when he had his injection his arm is very sore and felt like its gonna fall off; This is a spontaneous report from a contactable consumer. This report is for doctor of consumer.    A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient had his injection his arm is very sore and felt like its gonna fall off. The outcome of event was unknown,
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in extremity
Clinical narrative: After the first dose the caller's arm was still sore and tight before the second shot; After the first dose the caller's arm was still sore and tight before the second shot; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route on 20Mar2021 as 1st dose, single dose in the left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Mar2021, after the first dose the patient experienced arm was still sore and tight. After the first shot, the patient had arm soreness but nothing that was different from the reports. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on your legs; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the reporter just wanted to know if it was a normal reaction from Pfizer Vaccine to get a rash on your legs and all that. The reporter seriousness for the event was reported as unspecified. The reporter was informed about Pfizer Medical information department and was provided with the number. QR Comment included it could not be clarified if the caller was calling for self or for some other user, hence was the patient also the reporter. The outcome of the event was unknown.  Information on batch/lot number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: That day they diagnosed four other patients with Bell's Palsy who received Pfizer.; This is a spontaneous report from a contactable other hcp (nurse). A non-pregnant female patient of unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, on an unspecified date, as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06May2021, the patient experienced that day they diagnosed four other patients with bell's palsy who received Pfizer. The evet was medically significant. The patient was visited to emergency room. The outcome of the event was unknown.  Follow-up attempts needed; information about lot/batch no. requested. Further information expected.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of Bell's Palsy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021662119 same reporter/product/event, different patient
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; Tiredness; Headache; Nausea; Feeling unwell; Arm pain; Weakness; Short of breath; This is a spontaneous report from a contactable consumer (patient).    A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration, administered in Left arm on 03Jun2021 at 17:00 (at the age of 55-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. and the patient had no known allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, probiotic supplement (PROBIOTICS NOS) taken for an unspecified indication, on an unspecified date received in two weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185, Expiration date: unknown), via an unspecified route of administration, administered in Left arm on 13May2021 17:00 at the age of 55-years-old for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 04Jun2021 at 11:00, the patient experienced side effect Injections pain, swelling, redness, itching, Tiredness, Headache, Nausea, feeling unwell, Arm pain, Weakness and Short of breath. patient did not received any treatment for adverse events. The outcome of the events was unknown. .
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; Tiredness; Headache; Nausea; Feeling unwell; Arm pain; Weakness; Short of breath; This is a spontaneous report from a contactable consumer (patient).    A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration, administered in Left arm on 03Jun2021 at 17:00 (at the age of 55-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. and the patient had no known allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, probiotic supplement (PROBIOTICS NOS) taken for an unspecified indication, on an unspecified date received in two weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185, Expiration date: unknown), via an unspecified route of administration, administered in Left arm on 13May2021 17:00 at the age of 55-years-old for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 04Jun2021 at 11:00, the patient experienced side effect Injections pain, swelling, redness, itching, Tiredness, Headache, Nausea, feeling unwell, Arm pain, Weakness and Short of breath. patient did not received any treatment for adverse events. The outcome of the events was unknown. .
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; Tiredness; Headache; Nausea; Feeling unwell; Arm pain; Weakness; Short of breath; This is a spontaneous report from a contactable consumer (patient).    A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration, administered in Left arm on 03Jun2021 at 17:00 (at the age of 55-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. and the patient had no known allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, probiotic supplement (PROBIOTICS NOS) taken for an unspecified indication, on an unspecified date received in two weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185, Expiration date: unknown), via an unspecified route of administration, administered in Left arm on 13May2021 17:00 at the age of 55-years-old for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 04Jun2021 at 11:00, the patient experienced side effect Injections pain, swelling, redness, itching, Tiredness, Headache, Nausea, feeling unwell, Arm pain, Weakness and Short of breath. patient did not received any treatment for adverse events. The outcome of the events was unknown. .
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Slight headache; Sore arm; Tired; This is a spontaneous report from a contactable consumer (parent). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 02Jun2021 at 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 03Jun2021, patient woke up around 11am and had slight headache, which lasted all day, sore arm and tired. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: had an extreme reaction with her menstruation; extreme cramping which was shocking; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had the covid vaccine and had an extreme reaction with menstruation and extreme cramping which was shocking since there was no mention of this. After she started reading about other women facing the same issue, after first shot she found out Pfizer could not be bothered to care about what affects women participants. It was reported that she wants to understand, she matters, exist, and his gender makes up approximately 50% of the nation. This was disappointing and why there was a lack of trust with big pharma. The outcome of events were unknown.  Follow-up attempts are needed. Information on the lot/batch number is requested.