chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pruritus, Pyrexia, Somnolence
Clinical narrative: Itching; extreme tiredness and sleepiness; extreme tiredness and sleepiness; Headache; Muscle pain; Chills; Fever; Nausea; Feeling unwell; can't eat; problems with equilibrium; Cough; Sore throat; has not been eating; This is a spontaneous report from a contactable consumer or other non hcp. A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 14Jun2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. Medical history included immune deficiency (diagnosed 11 years ago), diabetes (diagnosed over 10 years ago). The patient's concomitant medications were not reported. The patient experienced has not been eating, extreme tiredness and sleepiness, headache, muscle pain, chills, fever, nausea, feeling unwell, can't eat, problems with equilibrium, cough, sore throat, all on 20Jun2021, Itching on 21Jun2021. The reporter is calling about the Pfizer covid vaccine on behalf of his wife. The reporter wants to report the patient's side effects. The patient has had complications starting on June 20th with severe, well not, but pretty close to it, symptoms. The patient has not been eating. Event: The patient has chills and keeps getting hot and cold. The patient is having problems with her equilibrium and stumbles and feels like she is drunk and is unbalanced. Outcome of the events was not recovered.   Follow up attempts are needed; Information on lot number/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0171, Expiry date: unknown), via unspecified route, administered on left arm, as dose 2, single, for covid-19 immunisation on 22Apr2021 at 09.00AM. Patient medical history was not reported. Concomitant medications included Bupropion, metformin, spironolactone and Prilosec (omeprazole). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8732 Expiry date: unknown), via unspecified route, administered on left arm, as dose 1, single, for covid-19 immunisation on 01Apr2021 at 02.00PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies. The patient experienced tinnitus on 29Apr2021. The patient did not receive any treatment for the event. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Vaccination site pain
Clinical narrative: Patient then started with joint and muscle pain; Patient then started with joint and muscle pain; She had injection site pain which she expected; However she started getting dizziness with headache; However she started getting dizziness with headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Jun2021 (Batch/Lot number and Expiry date was not reported) as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer COVID19 Vaccine 15Jun2021 and she had injection site pain which she expected, however she started getting dizziness with headache that started last week on an unspecified date in Jun2021 and continued until now. Patient then started with joint and muscle pain this past Saturday/Sunday (19Jun2021/20Jun2021). She went to the Emergency Room yesterday and was still waiting on her HCP to call her back as well. The outcome of events headache and dizziness was not recovered whereas other events were unknown.  Lot /batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Rash, Rhinorrhoea
Clinical narrative: Headaches; Bad rashes on top front of arms , neck and ear; Sinus issues/runny nose; Achey joints; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-year-old (non-pregnant) female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in arm right on 22Mar2021 (at the age of 68-year-old) at dose 2, single for covid-19 immunisation. Medical history included Known allergies: fresh strawberries and tomatoes, keflex, gentamycin. If covid prior vaccination: No. If covid tested post vaccination: No. If other vaccine in four weeks: No. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM); lisinopril (LISINOPRIL); glipizide (GLIPIZIDE). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in arm right on 20Feb2021 at dose 1, single for covid-19 immunisation. keflex [cefalexin] and experienced known allergies: keflex, gentamycin and experienced known allergies: gentamycin. On 30Mar2021 the patient experienced headaches, bad rashes on top front of arms, neck and ear, sinus issues/runny, achey joints. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received treatment for the adverse events. Outcome of the events was not resolved.   Follow-up (26Jul2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Had chest pain; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, NDC number and Expiry date: Not provided), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. No medical history and concomitant medications were reported. On an unspecified date the patient had chest pain. The additional context received as, the patient doctor said that there were patients who were having problems after the first shot. There was one guy who had chest pain. For some reason these adverse events happened about a week out when they started having problems. Caller declined to complete the safety report and only wants her question addressed, unable to obtain further details at this time. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: had swelled up lymph nodes; This is a spontaneous report from a contactable consumer. An unspecified aged female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as her doctor said that there were patients who were having problems after the first shot. The patient had swelled up lymph nodes on an unspecified date. For some reason these adverse events happened about a week out when they started having problems.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizzy; Headache; This is spontaneous report from contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: SA6780 (not clarified appropriately), Expiration date, NDC number, UPC number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizzy and headache. The patient wanted to know what to do with these side effects and wanted to talk to Pfizer Medical Information Department. The outcome of the events was unknown.  Follow-up attempts are needed. Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury, Neuralgia, Pain in extremity
Clinical narrative: they even bruised my nerves in my arm,  it doesn't hurts on the surface its deep inside; they even bruised my nerves in my arm,  it doesn't hurts on the surface its deep inside; I am limited with what I can do with arm because of the pain.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on 21Apr2021 as dose2, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for Covid-19 Immunization as first dose. The patient experienced they even bruised my nerves in my arm, it doesn't hurts on the surface its deep inside, i am limited with what i can do with arm because of the pain on an unspecified date. Patient stated, I had the Pfizer shot alright, the second shot of the Pfizer was on 21Apr this year ok, that's second shot my arm is still hurting ever since then. Patient got the shot at the VA clinic ok, patient kept call him back telling that am having pain in my arm with the shot with in. They tell me all, go way 2 more weeks back call him, okay. Patient talked several time with them, they are telling me, all we give you therapy, patient stated something is wrong with my arm, they even bruised my nerves in my arm, it doesn't hurts on the surface its deep inside and patient was limited with what patient can do with arm because of the pain. Patient want to know what the problem is. Patient called out to where the university office they said they doesn't see how any kind of therapy its gonna help what am telling with my arm, there are 4 different agencies and patient get around every time, something is wrong. Consumer was informed about medical information department. As consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call. The outcome of events was unknown.  Information regarding the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Headache, after second vaccine; Vomiting, after second vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 23Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization. In Jun2021, the patient experienced headache, after second vaccine and vomiting, after second vaccine. The consumer reported that the patient got his second dose the previous day. He woke up with a headache. The consumer gave him an Advil, and he quickly threw up. The consumer knew that a headache was a side effect. She asked what should she do for the regurgitation, was there a treatment that she should be giving her son. She further asked would that last a day, or was there something she needs to give him if he should vomit again. The consumer reclarified that she does not want a treatment, but really would like to know if the vomiting was normal after the vaccine for a child. She was referred to her son's pediatrician for treatment recommendations. The outcome of the events was unknown.  Information about lot number requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Rash
Clinical narrative: Rash on her side that showed up a week after; Has a lot of stomach problems; This is a spontaneous report from a contactable other non-healthcare professional or female consumer (patient) reported for herself.  A female patient of an unspecified age received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number: not reported )via an unspecified route of administration on 19May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash on her side that showed up a week after and has a lot of stomach problems. Investigation Assessment was not Provided. The outcome of the events was unknown. Patient said that her doctor told her that she should contact Pfizer, because she was about basically at wits end.  Follow-up attempts are needed. Additional information been expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: My sleep was disturbed was a while; This is a spontaneous report from a contactable Other Healthcare professional (patient).  A 36-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration, administered in Arm Left on 02Jun2021 (at the age of 36 years old) as dose 1, single for covid-19 immunisation. Medical history included HT (hypertension) from an unknown date and unknown if ongoing , hyperthyroidism from an unknown date and unknown if ongoing. Patient had no Known allergies. Concomitant medications included losartan potassium 100mg taken for an unspecified indication, start and stop date were not reported; levothyroxine 75mcg taken for an unspecified indication, start and stop date were not reported.  The patient experienced my sleep was disturbed was a while in Jun2021.It was reported that he had his first shot on 02Jun2021. With that he did not get many symptoms except his sleep was disturbed was a while. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for adverse events. The outcome of event was recovered on an unknown date in Jun2021.   Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives/hives were mostly concentrated on the arm where he got the shot; This is a spontaneous report from a contactable consumer(patient). A 52-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the right arm on 24Jun2021 (at the age of 52-years-old) at single dose for covid-19 immunization. The patient medical history included diabetes and schizophrenia. The patient's concomitant medications included metformin, glipizide, enapril maleate (ENALAPRIL), atorvastatin, risperidone. The patient previously received pneumonia and flu shot last month in May2021 (at the age of 52-years-old) for immunization. The patient wanted to know if hives were among the reported adverse events after getting the Pfizer BioNTech Covid-19 Vaccine. The patient started experiencing hives on 24Jun2021, the hives went away for a while but came back. He stated that the hives were mostly concentrated on the arm where he got the shot. The patient got the vaccine on 24Jun2021 and he broke out in hives. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Fatigue, Pain
Clinical narrative: difficulty breathing; strong internal chest pain that gradually subsided; chills; fever; body pain; exhaustion; This is a spontaneous report from a contactable health care professional (patient's mother). A 16-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via intramuscular in the right arm on 14Jun2021 03:45 PM (at the age of 16-years-old) at single dose for covid-19 immunization. The patient medical history included that prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. There was no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced approximately 24 hours of difficulty breathing and strong internal chest pain that gradually subsided, along with chills fever, body pain, and exhaustion on 15Jun2021 06:00 AM. No treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jun2021. The report was reported as non-serious.   Information on the lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: difficulty breathing; strong internal chest pain that gradually subsided; chills; fever; body pain; exhaustion; This is a spontaneous report from a contactable health care professional (patient's mother). A 16-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via intramuscular in the right arm on 14Jun2021 03:45 PM (at the age of 16-years-old) at single dose for covid-19 immunization. The patient medical history included that prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. The patient was not pregnant at time of vaccination. There was no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced approximately 24 hours of difficulty breathing and strong internal chest pain that gradually subsided, along with chills fever, body pain, and exhaustion on 15Jun2021 06:00 AM. No treatment was received for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jun2021. The report was reported as non-serious.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: test on 02Feb2021 came back positive; test on 02Feb2021 came back positive; ran a fever; i was barely sick; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) intramuscularly, administered in left deltoid on 16Jan2021 (at the age of 65-year-old) as single dose for Covid-19 immunisation in workplace clinic. Medical history included, the patient had in lifetime, 3 episodes of vasovagal syncope in her lifetime (all related to blood draws) and her blood pressure was naturally low. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the first administration date of the suspect vaccine. The patient did not receive any other concomitant medication within two weeks before the event onset. On 30Jan2021, the reported that she ran on fever and started isolated. The patient was barely sick enough to warn me to isolate, possibly because the first shot had already generated some useful antibodies. On 02Feb2021 came back positive to COVID 19. Clinic on 06Feb2021 was clearly not helped the patient. The clients, however, were cleared from isolation in time to get their second shots on the 06Feb2021. Staff later told patient; the whole house was wiped out the next day. Everybody wanted to stay in bed, some even refused meals in favor of rest. Our whole group home, all clients and every staff that consented, got the first shot at the office on 16Jan2021. Clinics scheduled 3 weeks apart, so the second shot was due on 06Feb2021. After that, 27Feb2021, and so on until no one needed the second shot anymore. The patient was very relieved to finally get her turn to get the vaccine. Unbeknownst to her, one of the staff (who did not take the shot that day) had infected by her S.O. and was industriously exposing the clients the very day they were getting their shots. She worked double shifts two days in a row just before she started showing symptoms, so, max exposure. The patient did her best with the masks and bunny suits but was not trained nurse, and the house was just a virus stew by that point. She could not exactly open all the windows in the month of January. The patient lab test included SARS-COV-2 test was positive on 02Feb2021. Outcome of the events was unknown.  Follow up attempts are not possible. No further information is expected.; Sender's Comments: Based on the know safety profile and limited information in the case, a contributory role of BNT162B2, to the reported events cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Pain
Clinical narrative: I did have the normal aches; chills; This is a spontaneous report from a contactable other hcp/nurse (patient). A 81-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation (age at vaccination: 81 years).  The patient medical history was not reported. Concomitant medication included levothyroxine (LEVOTHYROXINE). The patient had an adverse reaction to Latanoprost (manufacturer name not clarified hence is this Pfizer product left unchecked) and the patient just you know, it was severe and I am still having some effects all over on other side of bridge. The patient just want to report it, that it was a significant reaction requiring emergency room visit, the patient probably should have been hospitalized, it's been a long time resolving and I had definitely a severe upper respiratory tract infection like inflammation COVID whatever although, the patient had in January 20, I had, I feel like I had COVID(Further clarification unknown) I didn't get tested because they weren't testing at that time and I had both of my vaccine. So, the patient started off with just you know the cough and then it went progressive and bronchospasm, unable to breath, you know my eye lashes are darker and they are like having mascara and they had drastic change. The patient meant, they are not bad but I am light brown and they are black. So, that would be (When probed if adverse effects caused from Latanoprost or Pfizer COVID-19 Vaccine (Captured as suspect): Nurse stated, "Latanoprost, that's what the patient asked for it not the vaccine. No, the patient had the vaccine, the patient had no reaction but I did have the normal aches, I had like a few hours of chills, I had expected reaction from the vaccine. No problem, but the Latanoprost was it is close to death that I have even been."). The patient experienced I did have the normal aches and chills on an unspecified date. The patient underwent lab tests and procedures which included lungs and my chest X-rays: normal on an unknown date. Outcome of both the events (I did have the normal aches and chills) was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia
Clinical narrative: painful muscle; muscle is tight and being pulled and its hasn't gone away; This is a spontaneous report from contactable consumer. A 72-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 as dose 1, single dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced painful muscle on his left arm after a couple of days. She experienced muscle pain whenever she is reaching above or behind. On her second shot, she reported the side effect with the pharmacist and was told the pharmacist is not aware or known to this side effect. The muscle in her upper arm on the inside was painful when she would reach behind her or up above, left arm. Pfizer shot on 27Apr2021 and a couple days after that she noticed the muscle in her upper arm on the inside was painful when she would reach behind her or up above and she mentioned it to the pharmacy when she got her second shot, and (name withheld) the pharmacist hadn't heard about that kind of reaction before. Caller states she got her second shot and she's still having that muscle pain when she reaches behind her with that arm or when she reaches up. Caller states its almost like the muscle is tight and being pulled and its hasn't gone away.  That information on the Lot/batch number has been requested
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: left forearm, left middle finger and abdomen rash; This is a spontaneous report from a contactable consumer. This 52-year-old male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 26Jun2021 at dose 1, single for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Consumer asking should I get the second dose of the Pfizer Covid-19 Vaccine after experiencing left forearm, left middle finger and abdomen rash after receiving the first dose on 26Jun2021. : Possible duplicate AE information e-transmitted. The outcome of event was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Sluggishness, Somnolence
Clinical narrative: Sleepy; tired/feeling fatigued; itching on left arm; She is pushing her self and she feels sluggish.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EL9269, expiration date was not reported) via an unspecified route of administration in the left arm on 13Feb2021 between 2-4pm (at the age of 65-years-old) at single dose for covid-19 immunisation. Medical history and concomitant medications were reported as none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no additional vaccines administered on same date of the Pfizer Suspect. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EL3248, expiration date was not reported) via an unspecified route of administration in the left arm on 23Jan2021 (at the age of 65-years-old) at single dose for covid-19 immunisation and no adverse effect. The patient received the second dose on 23Jan2021 between 2-4pm and was having a reaction. The patient stated that she told them at her job that she had been tired since getting the vaccine. They jokingly told her she was getting old. The patient was a strong person. On her 2 days off from work she was resting and sleeping. She was pushing herself and she felt sluggish in 2021. On 14Feb2021, the day after she received the second dose she was sleepy, she was tired and her left arm was itching. Since, the patient had been feeling fatigued, and sleepy even though she got 7 hours of sleep. There were no relevant tests. The patient stated that she mentioned to a doctor that she was feeling tired, and the doctor suggested that she should take vitamins, B-12 to help with energy and wait another month since the doctor was aware that the Pfizer Covid vaccine can cause tiredness. The treatment received for event tired/feeling fatigued was vitamins, B-12. Events sleepy, itching on left arm and felt sluggish did not require a visit to emergency room nor physician office. The outcome of events sleepy and tired/feeling fatigued was not recovered. The outcome of event itching on left arm was recovered on 15Feb2021. The outcome of event felt sluggish was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Palpitations
Clinical narrative: heart palpitation; irregular heart beats/irregular beats that happening and seems like it's like every 20 minutes; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ER2613, expiration date was not reported) via an unspecified route of administration in the left arm on 02Jun2021 (at the age of 46-years-old) at single dose for covid-19 immunisation. The patient medical history and concomitant therapy were none. The patient was fine on the weekend and he didn't get any adverse side effect things, so he was noticing some heart palpitation, the heart was not regular pattern, irregular heart beats, he was noticing some irregular beats that happening and seemed like it was like every 20 minutes, he wanted to know this was normal or not and the only thing he took over the counter was some Advil (Ibuprofen ) just because of this irregular heart beat thing. No treatment received for the event heart palpitation. The outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Functional gastrointestinal disorder
Clinical narrative: Digestive problems; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28May2021 (Batch/Lot Number: ER8735) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal disorder from an unknown date and unknown if ongoing (So my experience in the past if I have some kind digestive issue I go on very careful diet for 3-4 days and it gets better). The patient's concomitant medications were not reported. The patient experienced digestive problems on 01Jun2021. patient stated, "So after the first shot, 4 days later I started to have digestive problems. So my experience in the past if I have some kind digestive issue I go on very careful diet for 3-4 days and it gets better, it improves but it didn't improved. When probed if patient took Famotidine and Gaviscon as a treatment of adverse event (digestive problems), patient stated, "Well I tried to take care of it myself but first, I tried Gas-X and then I tried TUMS, I tried Gaviscon and then when I went to the primary care she said try Famotidine which I did and you know, I couldn't take it at all, you know it's the way I can tell, as if I can see the prescription for the medicine (Famotidine) going up through my esophagus cavity and that kind of thing and I could tell it makes it worse, So I just stopped taking it. Yesterday when I went to the primary care physician, she said you know just go through the Gastroenterologist, then I have to wait another 10 days. I called 3 Gastroenterologist they said, they have put me on your waiting list and I haven't got any result from them for a long so, I don't know, I don't know what's next." Therapeutic measures were taken as a result of digestive problems. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle twitching, Pain, Paraesthesia, Tinnitus
Clinical narrative: horrible headache all the way down to her body; horrible headache all the way down to her body; Pulsatile tinnitus; it is going like tingling when touch her leg; it's like little like arm go to sleep it tingles but now starting to twitch giving her twitching you know for no reason; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an dose 1 via an unspecified route of administration on 13Apr2021 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took gabapentin. On Apr2021,After Three days of vaccination, the patient experienced horrible headache all the way down to her body, pulsatile tinnitus that you can hear heart beat in your ear and it started with that it went all of her into her face area and then down on left side it went down in her left arm and then her right left leg ,it is going like tingling when touch her leg, it's like little like arm go to sleep it tingles but now starting to twitch giving her twitching you know for no reason. The outcome of events was unknown.  Information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fear
Clinical narrative: Her father is scared either way; Her parents having been shot with Pfizer-BioNTech COVID-19 Vaccine that was beyond the total time of use; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's daughter). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 28Jun2021 (at 68-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included had multiple health conditions and concomitant medications were not reported. Reporter calling about her parents having been shot with Pfizer-BioNTech COVID-19 Vaccine that was beyond the total time of use. Caller stated that her parents got their 1st dose of vaccine on 28Jun2021, however, they were informed on 02Jul2021 that the vaccines were expired (start date 28Jun2021). According to them, the vials was supposed to expired in Aug2021, but the vial has been stored in the fridge for 38 days and you're not supposed to use it after 31 days. The vaccine shot that was in the refrigerator for 38 days was still given to reporter's parents. The patient (her father) was the very concern and had multiple health conditions and was afraid of allergic reactions. The patient wanted to make sure that if he doesn't get revaccinated, he was still protected. The patient was scared either way on unspecified date. Reporter wanted to know if they should be revaccinated or to resume the vaccination series as scheduled or was it safe to use the 38 days; and let's say they want to get revaccinated and decided to go for the full MODERNA series instead of Pfizer because they fear getting Pfizer again since they already got one shot, what was the data Pfizer have on people getting one shot of something and change to a different COVID Vaccine.  Information on lot /batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021865048 same reporter/drug/AE, different patient
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Fatigue, Feeling hot
Clinical narrative: feel lightheaded; tired; couldn't relax; a slight fever; she feels hot after getting the vaccine; I was sweating a little more than normal on my forehead; my joint pain was more than normal; I had something already bothering my left foot on my toe; Headache; This is a spontaneous report received from a contactable consumer who reported for herself. This report is also reported from a Pfizer sponsored. A 69-year-old female patient received her first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration at 0.3 mg as a single dose on 18Jun2021 (lot number EW0179, expiration date Aug2021), for COVID-19 immunization. The patient had food allergies and weather issues like when the seasons change like pollen. Concomitant medications were not reported. At the day of vaccination (18Jun2021), the patient was tired and couldn't relax. And then she might have had a slight fever too and she felt hot, but it was hot that day too. She was sweating a little more than normal on her forehead. And her joint pain was more than normal. She had something already bothering her left foot on her toe. It seemed liked everyday for a while. She did something to her toe about 2 months now. When she standed or walked too long she felt lightheaded, but she had had that before. She might have felt a little lightheaded before she left the hospital too. She was there for 15 or 20 minutes before she left but she had someone with her. Also it was not too much of a headache, she did have some days where she felt light headed or dizzy, like when she first got up. The patient didn't want to get the Johnson and Johnson vaccine because of the things with the veins and legs and she had a lot of veins in her legs, she was hoping that Pfizer's vaccine did not affect the veins. The outcome of the events was unknown. The patient's second dose was scheduled on 09Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Limb discomfort, Pyrexia, Restlessness
Clinical narrative: feel lightheaded; tired; couldn't relax; a slight fever; she feels hot after getting the vaccine; I was sweating a little more than normal on my forehead; my joint pain was more than normal; I had something already bothering my left foot on my toe; Headache; This is a spontaneous report received from a contactable consumer who reported for herself. This report is also reported from a Pfizer sponsored. A 69-year-old female patient received her first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration at 0.3 mg as a single dose on 18Jun2021 (lot number EW0179, expiration date Aug2021), for COVID-19 immunization. The patient had food allergies and weather issues like when the seasons change like pollen. Concomitant medications were not reported. At the day of vaccination (18Jun2021), the patient was tired and couldn't relax. And then she might have had a slight fever too and she felt hot, but it was hot that day too. She was sweating a little more than normal on her forehead. And her joint pain was more than normal. She had something already bothering her left foot on her toe. It seemed liked everyday for a while. She did something to her toe about 2 months now. When she standed or walked too long she felt lightheaded, but she had had that before. She might have felt a little lightheaded before she left the hospital too. She was there for 15 or 20 minutes before she left but she had someone with her. Also it was not too much of a headache, she did have some days where she felt light headed or dizzy, like when she first got up. The patient didn't want to get the Johnson and Johnson vaccine because of the things with the veins and legs and she had a lot of veins in her legs, she was hoping that Pfizer's vaccine did not affect the veins. The outcome of the events was unknown. The patient's second dose was scheduled on 09Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Fall
Clinical narrative: Her mother had a couple falls within a couple days; Her mother had 2 ankle fractures from one of the falls; This is a spontaneous report from a contactable consumer or other non-hcp. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6204; Expiration Date: Jun2021) via an unspecified route of administration (age at vaccination 71-year) in Right Arm on 10Mar2021 as dose 1, single for COVID-19 immunization. Medical history included crohn's disease from 1980 to an unknown date; pulmonary fibrosis (diagnosed 2 years ago), fibromyalgia (for at least a decade), arthritis, stress fracture, ankle fracture, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No prior Vaccinations (within 4 weeks) was reported. As patient's daughter reported, her mother had a couple falls within a couple days on 28Mar2021; her mother had 2 ankle fractures from one of the falls in 2021. The caller said her mother had a fall, and her mother had not gotten her second COVID-19 Vaccine dose. The caller asked if her mother should start over with getting the COVID-19 Vaccine, or could her mother get the second COVID-19 Vaccine dose. Person stated she gave the caller the number for Pfizer Medical Information. Reviewed and confirmed the transferring agent's report details with the caller. Reported she didn't believe that her mother's fall was related to her mother's first COVID-19 Vaccine dose. She said there was too much time that had gone by between when her mother received her first COVID-19 Vaccine dose and her mother's fall. Stated her mother said she believed she received her first COVID-19 Vaccine in her right arm because she was left-handed but was not positive. Reported her mother had past stress fractures and did not realize she had 2 ankle fractures. She said she called EMS the following day of her mother's fall, and her mother didn't have surgery on her foot right away because she had too much swelling. She clarified her mother had surgery on her one foot at a later date. Reported her mother was in a residential care facility for 2 months and had to cancel her second COVID-19 Vaccine. She said her mother was unable to get another COVID-19 Vaccine appointment during that time, and the residential care facility her mother was in used a different COVID-19 Vaccine. Her mother not getting her second COVID-19 Vaccine was strictly a timing issue because she was unable to schedule a Pfizer COVID-19 Vaccine while at the residential care facility. The adverse event ankle fracture leads to visit Emergency Room/Physician Office. Her mother had surgery one her foot, and her mother was in a skilled nursing rehab center for 2 months. No further details provided. Her mother was still in recovery with Physical Therapy and Occupation Therapy being done at home. Therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events was recovering.  Follow-up attempts are needed. Further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nausea
Clinical narrative: Nausea; fatigue; decreased appetite; This is a spontaneous report from a contactable physician.  A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose intramuscularly, administered in Arm Right on 05Apr2021 (Lot Number: EW0150, expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation.  Medical history included neoplasm left kidney from 2007 to an unknown date. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route on 15Mar2021 (Lot Number and expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation and experienced Nausea. The patient experienced nausea, fatigue, decreased appetite, all in 2021. Nausea, fatigue and decreased appetite which has persisted after his second Pfizer COVID-19 vaccine 05Apr2021. The outcome of the events was not recovered. The report was reported as non-serious. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for events.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Neck pain, Pyrexia, Vaccination site pain
Clinical narrative: pain in the injection site; fever of 37.7 °C; pain in his neck; This is a spontaneous report from contactable consumer. This consumer reported for his children (patient).  A 12-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 08Jul2021 (at the age of vaccination 12-year-old) as dose number unknown, single for covid-19 immunization.The patient's medical history and concomitant medications were not reported. It was reported that yesterday reporter and children (patient) both were vaccinated with the Pfizer Covid-19 vaccine around noon. On 08Jul2021 at night, one of the children had pain in his neck, the other malaise and reporter gave them paracetamol. On 09Jul2021(Today), they have a fever of 37.7 degree C and pain in the injection site. The patient underwent lab tests which included body temperature: 37.7 centigrade on 09Jul2021.The outcome of all events was unknown.  Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021875528 same reporter/ drug, different AE/patient
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Muscle spasms
Clinical narrative: bloating; abdominal pain; Cramping; stomach bloated, like it was filled gas, with severe pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA6780), via an unspecified route of administration in the left arm on 08Jul2021 (at the age of 61-year-old) as dose 2, single for COVID-19 immunisation. Medical history included acid reflux from an unknown date and unknown if ongoing, sjogren's syndrome from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole (started about 4-5 years ago) taken for acid reflux disease from an unspecified start date and ongoing; cevimeline (about 4-5 years) taken for sjogren's syndrome from an unspecified start date and ongoing; cyanocobalamin (B-12) (started this in the last month and for to be healthy) taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration in the left arm on an unknown date as dose 1, single for COVID-19 immunisation. It was reported that the she got the second Pfizer COVID vaccine shot yesterday, 08Jul2021, and not sure if this is a side effect or not, states she pretty active yesterday, but after lunch about 3-4 hours after the vaccine her stomach got very bloated, like it was filled with gas, had severe pain and cramping, abdominal pain, stated that subsidized with heating pad that evening but bloating and abdominal pain was coming back "today", bloating and abdominal pain was tender to the touch, has improved some. Caller was wondering if these are side effects that has been reported with the Pfizer COVID-19 vaccine. The patient was received treatment for the events. The outcome of the events was resolving.  Follow-up attempts are needed. Additional information has been requested.