chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Varicose vein
Clinical narrative: I have the vaccine got the night, yesterday and I get sick; I have my veins on my leg popped out, in case  in my veins, lot of boils.; I have my veins on my leg popped out, in case  in my veins, lot of boils.; one side like my legs, just don't have the power; I am tired already and I don't feel well; I had lot of bones feel bad in my neck; I am tired already and I don't feel well; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Solution for injection; Lot Number: EW0187, Expiration date: 31Aug2021) via an unspecified route of administration on 29Jun2021 as a dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had got the vaccine the night yesterday and got sick. She had her veins on leg popped out in case as lot of boils. "Popped out, out, you know when your veins gets bigger, this is popped off. When your veins get bigger and make a boils in there. You know what is a boils, like one little ball." She had a concern, why she had that? Is it going to worse or is it going to be disappear or what is going to do that to me? I need to know why, first place. Second place, if its not danger. Third place, if its going to be disappear. Patient stated that she don't want and no other get problems with the vaccine. The patient stated, "No, I am not. I am tired already. I am tired already and I don't feel well." and hung up the call, hence limited information available over the call." The patient further stated that she had pain in left leg and feel like, she was going to one side like her legs, just don't have the power. Additional information included that patient reported that she had yesterday, the Pfizer BioNTech covid-19 and today a very bad plug, in veins, pop off and had lot of bones feel bad in my neck. She wants to know what I can do? If its bad or is going away or what happen and also she had pain in my leg. Like in my left leg and I feel like, I am going to one side like my legs, just don't have the power. Therapeutic measures were not reported. Clinical outcome of the event was unknown.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Blacked out on day 2, 24+hrs after dose 2; This is a spontaneous report from a contactable consumer (patient).  A 13-year-old female patient received second dose of BNT162B2 via an unspecified route of administration at arm right on 06Jun2021 10:30 (age at 13 years old, Batch/Lot Number: Ew0191) as single dose for COVID-19 immunisation. The patient had no known allergies and other medical history. The patient received first dose of BNT162B2 on 16May2021 10:30 (lot number Ew0185) at arm right for COVID-19 immunisation. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced blacked out on day 2, 24+hrs after dose 2 on 07Jun2021 13:00. No treatment received. The outcome of the event was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Malaise, Muscular weakness
Clinical narrative: severe muscle weakness; felt unwell; she felt dizzy; had a brain fog but gone now; lousy; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Unknown) via an unspecified route of administration on 01Jun2021 (at the age of 84 years old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Unknown) via an unspecified route of administration on 11May2021 as dose 1, single for COVID-19 immunization. On 01Jun2021, after 40 minutes of receiving the vaccine, patient experienced severe muscle weakness, dizziness, felt lousy and felt unwell. Patient also had a brain fog along with felt dizzy, lousy but gone at time of reporting. Patient wanted to know what she can do to end the side effects sooner because it was already 1 month. She took tylenol and took lots of water to manage the side effects. She did mention that it was better now but it does not go away. She had some health issues and does have muscle weakness periodically. The outcome of the event severe muscle weakness and felt unwell was recovering, she felt dizzy, lousy and had a brain fog recovered on an unspecified date in 2021.  Information on Lot/Batch information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Platelets dropped 20 points after first week and then another 20 points, second week afterwards and actually 20 points within 5 days; This is a spontaneous report from a contactable consumer (patient wife) or other non hcp. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband had his first Pfizer shot and his platelets dropped 20 points after first week and then another 20 points, second week afterwards and actually 20 points within 5 days and platelet count was low anyways. She wanted to know, what would happen when he gets his second shot." The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Adverse drug reaction, Arthralgia, Contusion, Fatigue, Gait disturbance
Clinical narrative: She is having hard time walking/can hardly walk; Swelling/swelling at the arm of injection site one and a half days; Different things; Issues with right leg; Joint pain/has pain from top of the right leg to right knee; Bruised; Nausea; Tiredness; Arm pain as well; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0198), via intramuscular in left arm on 28JUN2021 at 10:30 (at the age of 66-years-old) as first dose, single for COVID-19 immunization. The patient also received Paracetamol (TYLENOL 8 HOUR) and Naproxen sodium (ALEVE) both on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included history of arthritis and Apr2020 (last year) she had surgery to remove a sarcoma from right hip/buttock and was unsure if that had anything to do with her right leg in the condition that she reported below post vaccination. The patient concomitant medication was not reported. On an unspecified date in 2021, patient experienced joint pain, swelling and "different things" and issues with right leg as she was having hard time walking. The minute she received the injection she experienced swelling and it lasted for 1.5 days, it was bruised, and she iced it per vaccine provider recommendations. Places where she is arthritic, she had experienced swelling. She also experienced nausea and tiredness post vaccination. On 28Jun2021 at 10:30, she had swelling arm/Injection site swelling one and a half days. On 29Jun2021, she could hardly walk on right leg. She reported that there was pain/aching in right leg from the top of leg to the knee. Patient also reported that her vaccine provider (Pharmacist) experienced bad arm pain as well. The girl that vaccinated patient called her to check in to see if swelling had gone down. Vaccine provider told patient that she personally took Tylenol. Vaccine provider said that studies have not been 100% sure if Aleve lessens the effects. She could probably take Tylenol if had to but that did not help her there, the only thing that really helped her was Aleve so, she was wondering if she could take an Aleve or not. The patient was not taking any treatment drug. The outcome of event (leg pain) was not recovered, swelling at vaccination site was recovered on 29Jun2021 at 22:30 and rest of all events were unknown.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Limb discomfort, Nausea, Pain in extremity, Vaccination site swelling
Clinical narrative: She is having hard time walking/can hardly walk; Swelling/swelling at the arm of injection site one and a half days; Different things; Issues with right leg; Joint pain/has pain from top of the right leg to right knee; Bruised; Nausea; Tiredness; Arm pain as well; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0198), via intramuscular in left arm on 28JUN2021 at 10:30 (at the age of 66-years-old) as first dose, single for COVID-19 immunization. The patient also received Paracetamol (TYLENOL 8 HOUR) and Naproxen sodium (ALEVE) both on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included history of arthritis and Apr2020 (last year) she had surgery to remove a sarcoma from right hip/buttock and was unsure if that had anything to do with her right leg in the condition that she reported below post vaccination. The patient concomitant medication was not reported. On an unspecified date in 2021, patient experienced joint pain, swelling and "different things" and issues with right leg as she was having hard time walking. The minute she received the injection she experienced swelling and it lasted for 1.5 days, it was bruised, and she iced it per vaccine provider recommendations. Places where she is arthritic, she had experienced swelling. She also experienced nausea and tiredness post vaccination. On 28Jun2021 at 10:30, she had swelling arm/Injection site swelling one and a half days. On 29Jun2021, she could hardly walk on right leg. She reported that there was pain/aching in right leg from the top of leg to the knee. Patient also reported that her vaccine provider (Pharmacist) experienced bad arm pain as well. The girl that vaccinated patient called her to check in to see if swelling had gone down. Vaccine provider told patient that she personally took Tylenol. Vaccine provider said that studies have not been 100% sure if Aleve lessens the effects. She could probably take Tylenol if had to but that did not help her there, the only thing that really helped her was Aleve so, she was wondering if she could take an Aleve or not. The patient was not taking any treatment drug. The outcome of event (leg pain) was not recovered, swelling at vaccination site was recovered on 29Jun2021 at 22:30 and rest of all events were unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Pain, Peripheral swelling
Clinical narrative: pain and soreness in her back and shoulder,; pain and soreness in her back and shoulder,; pain, the regular soreness; she was feeling the armpit pain; swollen arm/whole right arm and hand swollen; armpit is painful and swollen; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient) reported that a 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration in right arm on 29Jun2021 at 08:17 (at the age of 21 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not had history of previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had initial onset of side effects on 30Jun2021 starting with pain, the regular soreness; then she was feeling the armpit pain and then slowly during the day started feeling the back pain; she is having back pain and her whole right arm and hand are swollen. She is not sure about the back pain; she can't sleep on her right arm because of having the vaccine shot and usually she sleeps on that side; so it could be that being tensed up from not sleeping on the right side could have caused the back pain. The armpit pain and swelling of right arm and hand she is not sure about. She is experiencing swollen arm, armpit is painful and swollen, pain and soreness in her back and shoulder, whole right arm and hand swollen. She asked for further information about these side effects. She specified outcome of side effects as persistent. The patient did not visit emergency room or physician office. Treatment received: Tylenol 500mg every 6 hours after the vaccine for the soreness; they told her to take it so she did and it helped the pain come down a little bit. Tylenol: Lot: SMA034, Expiry: Aug2022, UPC: Unknown, but . The outcome of events was not recovered.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: pain and soreness in her back and shoulder,; pain and soreness in her back and shoulder,; pain, the regular soreness; she was feeling the armpit pain; swollen arm/whole right arm and hand swollen; armpit is painful and swollen; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient) reported that a 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration in right arm on 29Jun2021 at 08:17 (at the age of 21 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not had history of previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had initial onset of side effects on 30Jun2021 starting with pain, the regular soreness; then she was feeling the armpit pain and then slowly during the day started feeling the back pain; she is having back pain and her whole right arm and hand are swollen. She is not sure about the back pain; she can't sleep on her right arm because of having the vaccine shot and usually she sleeps on that side; so it could be that being tensed up from not sleeping on the right side could have caused the back pain. The armpit pain and swelling of right arm and hand she is not sure about. She is experiencing swollen arm, armpit is painful and swollen, pain and soreness in her back and shoulder, whole right arm and hand swollen. She asked for further information about these side effects. She specified outcome of side effects as persistent. The patient did not visit emergency room or physician office. Treatment received: Tylenol 500mg every 6 hours after the vaccine for the soreness; they told her to take it so she did and it helped the pain come down a little bit. Tylenol: Lot: SMA034, Expiry: Aug2022, UPC: Unknown, but . The outcome of events was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: She can't walk anymore.; The initial case was missing the following minimum criteria: ICH-unspecified AE. Upon receipt of follow-up information on [02Jul2021], this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) reported for herself via telephonic activity. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0180)dose 2, via an unspecified route of administration on 09Jun2021 (at 53 years of age) as 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, Lot number: EW0168) on 19May2021 (at 53 years of age) via an unspecified route of administration as single dose for Covid-19 Immunization. The patient stated first dose Pfizer Vaccine was received 21 days before the second dose Pfizer Vaccine. She received the second dose Pfizer Vaccine and had a reaction and is in the hospital. She states she and the doctor are trying to reach out to Pfizer to see if Pfizer can give some type of recommendation on what Pfizer does if someone has a reaction to the Pfizer Vaccine. She states she is laying there and cant do anything and can not walk or do anything. She cannot walk anymore. She is still in the hospital. The outcome of event was not recovered.  Follow up needed, further information has been requested.  Follow-Up 14Jul2021: Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Peripheral swelling
Clinical narrative: She had swelling in the lymph nodes of both armpits; She got her second COVID-19 Vaccine dose on 12Apr2021, and had swelling in her arm; She got her second COVID-19 Vaccine dose on 12Apr2021, and had a little feeling of being tired for 2 days.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number and Expiration date was unknown) via an unspecified route of administration on 12Apr2021 (at the age of 56-year-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient 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 unspecified date in 2021 as a single dose for COVID-19 immunization. Patient got her second COVID-19 Vaccine dose on 12Apr2021, and had no big things happened/did not experienced any big reaction, except swelling in her arm (arm swelling), and a little feeling of being tired for 2 days on an unspecified date in Apr2021. She said after those 2 days she had been feeling well. She said the day before yesterday (29Jun2021), she had swelling in the lymph nodes of both armpits. She said she was going to see her doctor (about the swollen lymph nodes) but wanted to doublecheck with Pfizer to see if having the swollen lymph nodes in both armpits so long after her second COVID-19 Vaccine dose was normal. She said she knew of other people who had swollen lymph nodes in their armpit the day after getting their COVID-19 Vaccine shot. She said the swelling in the lymph nodes of both armpits was strange for her, and she wanted to contact Pfizer to see what to do to prepare for her doctor's appointment. She took tylenol and she was feeling better. She did not feel it anymore on left arm, but still feels on right arm. She stated that her husband said that patients had been reporting this effect days after, but it was been weeks after the vaccine. The outcome of the event she had swelling in the lymph nodes of both armpits was not recovered and the rest of the events was recovered on an unspecified date in Apr2021.  Follow-up attempts are needed. Further information is requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Disturbance in attention, Feeling abnormal, Migraine
Clinical narrative: lack of focus; no energy; migraines; mental fog; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer RX Pathways.  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0196) via an unspecified route of administration on 07Jun2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0171) via an unspecified route of administration on 17May2021 as DOSE 1 SINGLE for COVID-19 immunisation. The patient received both doses of vaccine. The patient had rather severe side effects to include lack of focus, no energy, migraines (increased), and mental fog. It had been over three weeks since his second dose. The patient was not recovered from the events.  Follow-up attempts are not possible. No expected further was information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer via a female patient of an unspecified age received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical and concomitant medications were not reported. On an unspecified date the transferring agent stated, I have a patient on the other line the reason for the transfer is she would like to know if she can take Tylenol or blood pressure pills (Further clarification unknown hence not captured in tab) after the vaccine, the reason why the transfer is she had a fever after the 1st dose of Pfizer Covid-19 vaccine. When asked is there anything you want to add, the transferring agent stated, He disconnected So, I gave you the information. The outcome of the event was unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on unspecified date, at unknown dose single dose for COVID-19 immunisation. The patient's medical history included blood pressure. The concomitant medications were not reported. Patient received first dose of Pfizer covid-19 vaccine and had a fever afterwards. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: really bad arm pain; This is a spontaneous report from a contactable consumer via medical information team. A female patient (pharmacist) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported) via an unspecified route of administration in arm, on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after receiving the vaccination the patient really had bad arm pain. Patient personally took Tylenol as a treatment for the event. The outcome of the event was unknown.  Information about batch/ lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: I firmly believe that what is wrong with me, the vaccine triggered something in my body; I have had this cough since March; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified gender and age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history included cataract surgery. The concomitant medications were not reported. Patient firmly believed that what was wrong, the vaccine triggered something in the body. Patient got the Pfizer vaccine in Mar, the first part in Mar and  can look on card and give the dates. So, took one shot and in the meantime, was having cataract surgery and so, had one eye done and then had to wait for a week or so and then had the other eye done. When had the second eye done and had already taken the second vaccine and got something called episcleritis, it is autoimmune and they say it was not caused from the surgery. So two days after the second vaccine, got a stomach infection, had been tested by ENT, by the allergists and by doctor and they did not know, they said it was not sinus, it was not allergy and have had this cough since March. So was telling us something happened with that vaccine in body, firmly believed it. So when had this coughing, it is really weird, nose ran, usually the left side of nostril, nose, the left side ran and did not cough all the time but it was not going and had been on every medicine. Now was on medicine for acid reflux to see if that is the problem which did not really know if had acid reflux and had been taking this medicine for 3 days (further clarification about acid reflux is unknown, hence acid reflux captured as event) and  was about to switch to something more natural because did not know, tried not to take a whole lot of medicines, so had to stop taking it, it was dangerous. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pt received both doses of pfizer covid vaccine; Covid test post vaccination result: Positive; Pt received both doses of pfizer covid vaccine; Covid test post vaccination result: Positive; This is a spontaneous report from a contactable other health care professional. A 58-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN 3518), via intramuscular route of administration on 21Jan2021 (at the age of 57 years old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via intramuscular route of administration on 10Feb2021 as dose 2, single for covid-19 immunisation. At other facility the most recent COVID-19 vaccine was administered. Medical history included asthma, chronic pain, prediabetes and hypertension (HTN). The patient had no known allergies. Concomitant medications the patient received within 2 weeks of vaccination included amlodipine, gabapentin, fluticasone propionate, salmeterol xinafoate (ADVAIR), hctz, meloxicam, metformin, montelukast, tramadol; all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient received both doses of pfizer covid vaccine and had covid test post vaccination result: positive on 28Jun2021. The patient underwent lab tests and procedures which included rapid PCR: positive on 28Jun2021 (nasal swab). The events resulted in a visit to physician office. The patient did not receive any treatments for the events. Reporter considered events as non-serious. Outcome of the events was recovering.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, there is individual variation in how the body respond in developing antibodies to the vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Insomnia
Clinical narrative: Dose 2: bizarre dreams; Difficulty sleeping; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0191), via an unspecified route of administration on 27Jun2021 11:00 at left arm (at the age of 55-years-old) as Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other medication within 4 weeks prior to vaccinations. The patient previously received first dose of BNT162B2 (Lot number: EW0191) on 06Jun2021 11:00 at right arm for COVID-19 immunization and experienced neck pain, headache, thirst, diarrhea, kidney pain, burning in the back of the neck, sadness on 08Jun2021, congestion on 08Jun2021, cough, dizziness on 07Jun2021, difficulty sleeping. For dose two patient was not having any real side effects, not as bad. The only thing that she was still experiencing was the difficulty sleeping in 2021. However she thinks it was because of the dreams. Patient was having really bizarre dreams which began Sunday night, 27Jun2021. Patient was dreaming about everybody that has passed away in her life. Patient was just like, what does this mean. She clarified the events happened mainly in the morning and the things that were at night, were at night, however, the majority were in the morning. There were no additional Vaccines Administered on Same Date of the Pfizer Suspect. The adverse events did not require emergency room or physician's office. No relevant tests. The outcome of the events were not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021816851 similar report from same reporter
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Vomiting; Fever; Body aches; Headache; Painful injection site; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ew01), via an unspecified route of administration in arm left on 30Jun2021 at 11:00 (at the age of 24-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included COVID-19 from an unknown date and unknown if ongoing. The concomitant medications of the patient included lorazepam (LORAZEPAM), lithium (LITHIUM), quetiapine (QUETIAPINE) and one a day multi start date and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Since the vaccination, the patient not been tested with covid-19. On 30Jun2021 the patient experienced vomiting, fever, body aches, headache, painful injection site. The outcome of the events was reported as unknown.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Platelet count, Platelet count decreased, Pulmonary oedema
Clinical narrative: This is a spontaneous report from contactable consumer (patient). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: ER8734) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing, vitamin D deficiency from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (penicillin allergy). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 23Mar2021 (Batch/Lot Number: EN6208) age at vaccination of 68-years-old, for COVID-19 immunization. Concomitant medications included fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported; finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced low platelets, congestive heart failure, atrial fibrillation and pulmonary edema all started on 24May2021. The events resulted in doctor or other healthcare professional office/clinic visit; caused/prolonged hospitalization and life threatening. The patient was in ICU and was put on iv drip for congestive heart failure, cardizem drip. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness, Somnolence
Clinical narrative: Really tired for 3 weeks following the shot; Sick; Weak; Sleepy and couldn't stay awake; This is a spontaneous report from a contactable consumer (patient's daughter). An 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date, at the age of 82-years-old, as single dose for COVID-19 immunisation. Medical history included ongoing blood pressure; suffered from cramps (ongoing). The patient was in good health Family medical history was none. Concomitant medication included blood pressure medication for blood pressure from an unspecified date and ongoing. No additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). It was reported that the patient was really tired for 3 weeks following the shot. He was sick and weak. He was sleepy and just could not stay awake. Right after the patient got the shot, his symptoms started. The patient did not go to the doctor or the ER. He just got through it. He had no relevant tests done. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dermatitis, Dyspnoea, Potentiating drug interaction, Pruritus
Clinical narrative: trouble breathing so went to the ER; had a flare up that has gotten worse with expansion of a rash and blisters; had a flare up that has gotten worse with expansion of a rash and blisters; had a flare up that has gotten worse with expansion of a rash and blisters; "extreme itching" over the body; They are not sure if reaction is from the vaccine, Stelera, or the combination of both; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 23Jun2021 as dose 1 single (at the age of 67-year-old) for COVID-19 immunization. Medical history was not reported. Concomitant medications included ustekinumab (STELERA) from 19Apr2021 to 19May2021, hydrocortisone (HUMERA). On 24Jun2021, patient experienced a flare up that has gotten worse with expansion of a rash and blisters with extreme itching over the body and on 29Jun2021 was having trouble breathing so went to the ER, was treated and sent home. It was reported that patient was on Humera of years but back in Apr was started on Stelara  got first dose on 19Apr2021 and a second dose on 19May2021, patient spoke with HCP and getting the Pfizer COVID-19 vaccine and HCP said it was okay to do so patient received the first dose of the Pfizer COVID-19 on23Jun2021. On an unspecified date in Jun2021, they were not sure if reaction was from the vaccine, Stelera, or the combination of both, so looking to see if we have any information on this. Adverse reactions in clinical trials, adverse reactions in post authorization experience. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events dyspnoea, dermatitis, rash, blisters, pruritus, potentiating drug interaction and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: trouble breathing so went to the ER; had a flare up that has gotten worse with expansion of a rash and blisters; had a flare up that has gotten worse with expansion of a rash and blisters; had a flare up that has gotten worse with expansion of a rash and blisters; "extreme itching" over the body; They are not sure if reaction is from the vaccine, Stelera, or the combination of both; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 23Jun2021 as dose 1 single (at the age of 67-year-old) for COVID-19 immunization. Medical history was not reported. Concomitant medications included ustekinumab (STELERA) from 19Apr2021 to 19May2021, hydrocortisone (HUMERA). On 24Jun2021, patient experienced a flare up that has gotten worse with expansion of a rash and blisters with extreme itching over the body and on 29Jun2021 was having trouble breathing so went to the ER, was treated and sent home. It was reported that patient was on Humera of years but back in Apr was started on Stelara  got first dose on 19Apr2021 and a second dose on 19May2021, patient spoke with HCP and getting the Pfizer COVID-19 vaccine and HCP said it was okay to do so patient received the first dose of the Pfizer COVID-19 on23Jun2021. On an unspecified date in Jun2021, they were not sure if reaction was from the vaccine, Stelera, or the combination of both, so looking to see if we have any information on this. Adverse reactions in clinical trials, adverse reactions in post authorization experience. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events dyspnoea, dermatitis, rash, blisters, pruritus, potentiating drug interaction and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. 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.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Malaise, Paraesthesia
Clinical narrative: sweaty; heart rate became rapid; not to feel well; his arms and legs got tingly; This is a spontaneous report from a contactable consumer. This consumer (patients Grandmother) reported for a 13-year-old male patient (reporters Grandson) that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: EW0181 and Expiry date was not reported) via an unspecified route of administration in the right arm on 30Jun2021 (age at vaccination was 13-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On 30Jun2021 reporter stated on behalf of her 13-year-old grandson who received the Pfizer COVID-19 vaccine yesterday and did not experience any side effects until 7 pm that night when he went to an exercise class. She states that he started not to feel well, and his arms and legs got tingly, he became sweaty and rapid heartbeat for a short period of time. She states that by the time he got home he was feeling better. The patient took couple of tylenol and went to sleep and seem to be fine. Unspecified treatment received for the events. The outcome of the events was recovered on an unspecified date in 2021.  Follow up information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Pain in extremity
Clinical narrative: He developed weakness; Has been bedridden for the last 3 days; Complaining of pain to the arm; This is a spontaneous report from a non-contactable consumer (patients friend) via Pfizer sponsored program support. A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection), via an unspecified route of administration on an unknown date in Jun2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received vaccine about a month ago in 2021. He developed weakness and has been bedridden for the last 3 days in Jun2021 and complaining of pain to the arm in Jun2021. Patient friend considered this an emergency and wants to know what can be done for her friend. There is no PQC reported. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal infection, Cough, Episcleritis, Gastrooesophageal reflux disease, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer. This contactable consumer (patient) of unspecified age and gender reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number, UPC number: Unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number, UPC number: Unknown), via an unspecified route of administration on an unspecified date in the first part in Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included surgery. The patient's concomitant medications and past products were not reported. The patient took one shot and in the meantime, the patient was having cataract surgery (further clarification unknown) and one eye was done and then waited for a week or so and then had the other eye done. When the patient had the second eye done and the patient already taken, and could not remember, and already taken the second vaccine. The patient firmly believed that the vaccine triggered something in the body that was the reason for the wrong with the patient. The patient did not have the dates like right in front when all this happened to the patient but first, the patient got the Pfizer vaccine. The patient got something called episcleritis, it was autoimmune and they said it was not caused from the surgery. So, two days after the second vaccine, the patient got a stomach infection, the patient had been tested by 'ENT' (not clarified), by the allergists and by the doctor and they did not know, they said that it was not sinus, it was not allergy and the patient had this cough since March. So, when the patient had coughing, it was really weird, nose run, usually the left side of the nostril, patient's nose, the left side run and the patient did not have cough all the time but it was not going and the patient had been on every medicine (Unspecified Medication) whatever. Now, the patient was on medicine for acid reflux to see if that acid reflux was the problem and the patient have been taking this medicine for 3 days (further clarification about acid reflux was unknown) and the patient was about to switch to something more natural because the patient did not know and tried not to take a whole lot of medicines, so stop taking it, it was dangerous (not clarified further). The patient wanted to know if there were other people like the patient. The outcome of all events was unknown.  Information on lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Feeling hot, Headache, Muscular weakness
Clinical narrative: Muscle weakness; tired; Feeling hot; eyeball pain; Headache; Caller is the patient that received one dose of the Moderna Covid vaccine on 20 Jan 2021. Yesterday he received the Pfizer Biontech covid 19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program support. A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, expiry date: not reported) via an unspecified route of administration, administered in Arm Left, on 30Jun2021 at 15:00 ( at the age of 61 years), as 0.3 ML single for covid-19 immunisation. The patient received covid-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot Number: 027L20A), via an unspecified route of administration, on 20Jan2021 at standard dose, in left arm, for covid-19 immunisation and had a bad reaction to it. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior vaccination (within 4 weeks) was reported as the patient had shingles vaccine about a month ago. Family Medical History Relevant to AE was reported as no. On an unspecified date, the patient had experienced muscle weakness, tired, feeling hot, eyeball pain, headache. Reported feeling a little bit of eyeball pain, not bad and a little bit of a headache. The symptoms started the night before the day of reporting and most of the effects were on that night and on the morning of reporting. Stated his cup of coffee made him really hot. Side effects were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Adverse events did not require visit to emergency room or physician office. The outcome of the event headache was reported as recovered. The outcome of other events was unknown.