chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: magnetic area where the shot is administered/magnet sticks; This is a spontaneous report received from a contactable consumer (patient).  A male patient of an unknown age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient asked about the COVID vaccine, asked whether the patient could be put to ease about the magnetic area where the shot is administered which led to vaccination site reaction. She stated that she had done it to herself, friends, family, as well as complete strangers and the magnet sticks just to the area where they were injected. She would like to get the vaccine however any information on this matter is unavailable. Therefore, there is no information regarding events of magnetic effects at the site of injection. The clinical outcome of the event was reported as unknown.  As of 30Apr2021, safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed no spontaneous reports of magnetic properties at injection site since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. Also, a search of the published medical literature on 19May2021 failed to identify relevant information on this topic. Therefore, we are not aware of any information regarding events of magnetic effects at the site of injection.   Follow-up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 20May2021 as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced headache. It was reported that patient wanted to know if she can take Ibuprofen/Advil or pain reliever for headache. Customer and/or medical inquiry was not forwarded or referred to MI. The outcome of the event was unknown.  Information regarding the Lot/Batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: stuffy/runny nose; stuffy/runny nose; headaches; fever; congestion; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a 42-year-old male consumer patient (reporter's father) that, A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing blood pressure measurement, ongoing diabetes mellitus, ongoing hypersensitivity. It was reported that patient took medication for blood pressure, diabetes, and allergies. She does not have information with her. No further information provided. There is unknown Other Products and Patient History ware reported. No Investigation Assessment. It was reported that patient received his first Pfizer Covid vaccine dose on 20May2021. He has been experiencing a stuffy/runny nose, headaches, fever, and congestion. It was reported that patient got Pfizer vaccine first one 4 days ago on Thursday, 20 May2021. Patient having some side effects, stuffy runny nose, almost always clear liquid. Having headaches. Fever. Wants to know if there is something he can take or recommend. Having congestion as well. Going on for 4 days. Events started day of vaccination. Patient took Pfizer Covid Vaccine because he Wanted to be safe from virus, other family members got it. It was reported that patient has not done anything Treatment for event. Reporter seriousness for Stuffy runny nose, almost always clear liquid was unspecified. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Muscle spasms, Vomiting
Clinical narrative: One episode of vomiting; Leg spasms; Severe back pain; Chills; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: E087217 and Expiration Date was not reported) via intramuscular route of administration in Arm Left on 22Mar2021 10:00, as 2nd dose, single dose for COVID-19 immunization. Medical history included: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Incomplete Quadriplegic and in a wheelchair since 1972.  Immune and respiratory system are probably compromised since 1972. He was ambulatory up until 15 years ago. Concomitant medication(s) included celecoxib (CELEBREX) taken for arthralgia, myalgia from an unspecified start date to 2016.  Previously patient took first dose of BNT162B2 Injected intramuscularly in left arm on 01Mar2021. Patient stated he has 8 separate reactions since the second dose. Reported leg spasms, Severe back pain, chills and one episode of vomiting. Stated he was two months out and still getting them every 2 weeks. Reported that he was an incomplete quadriplegic since 1972. The dates as 25Mar2021, 30Mar2021, 04Apr2021, 05Apr2021 noting had the leg spasms, 06Apr2021 reported vomiting, 15Apr2021 had the fourth reaction that continued for 3 days noting they usually last 24 hours, 21Apr2021, 2May2021, 19May2021 and 21May2021. Patient stated he thought the frequency was getting longer up until last week. Wanted to know what type of doctor if any should he be talking to and if any-thing could be done other than taking Tylenol and if there have been reports of reactions continu-ally happening before. She received their first vaccine 01Mar2021, and second dose 22Mar2021, but was having same side effects 2 months out every 1 -2 weeks.  He was having leg spasms, severe back pain, and all kinds of side effects.  He was trying to figure out who can he talk to and how to manage these symptoms. Celebrex was the only thing he heard of that may have interacted.  He did not have a lot or expiration for that. NO ER or physician's office required. The outcome of the events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Fatigue, Feeling cold, Muscle spasms
Clinical narrative: One episode of vomiting; Leg spasms; Severe back pain; Chills; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: E087217 and Expiration Date was not reported) via intramuscular route of administration in Arm Left on 22Mar2021 10:00, as 2nd dose, single dose for COVID-19 immunization. Medical history included: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Incomplete Quadriplegic and in a wheelchair since 1972.  Immune and respiratory system are probably compromised since 1972. He was ambulatory up until 15 years ago. Concomitant medication(s) included celecoxib (CELEBREX) taken for arthralgia, myalgia from an unspecified start date to 2016.  Previously patient took first dose of BNT162B2 Injected intramuscularly in left arm on 01Mar2021. Patient stated he has 8 separate reactions since the second dose. Reported leg spasms, Severe back pain, chills and one episode of vomiting. Stated he was two months out and still getting them every 2 weeks. Reported that he was an incomplete quadriplegic since 1972. The dates as 25Mar2021, 30Mar2021, 04Apr2021, 05Apr2021 noting had the leg spasms, 06Apr2021 reported vomiting, 15Apr2021 had the fourth reaction that continued for 3 days noting they usually last 24 hours, 21Apr2021, 2May2021, 19May2021 and 21May2021. Patient stated he thought the frequency was getting longer up until last week. Wanted to know what type of doctor if any should he be talking to and if any-thing could be done other than taking Tylenol and if there have been reports of reactions continu-ally happening before. She received their first vaccine 01Mar2021, and second dose 22Mar2021, but was having same side effects 2 months out every 1 -2 weeks.  He was having leg spasms, severe back pain, and all kinds of side effects.  He was trying to figure out who can he talk to and how to manage these symptoms. Celebrex was the only thing he heard of that may have interacted.  He did not have a lot or expiration for that. NO ER or physician's office required. The outcome of the events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: One episode of vomiting; Leg spasms; Severe back pain; Chills; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: E087217 and Expiration Date was not reported) via intramuscular route of administration in Arm Left on 22Mar2021 10:00, as 2nd dose, single dose for COVID-19 immunization. Medical history included: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Incomplete Quadriplegic and in a wheelchair since 1972.  Immune and respiratory system are probably compromised since 1972. He was ambulatory up until 15 years ago. Concomitant medication(s) included celecoxib (CELEBREX) taken for arthralgia, myalgia from an unspecified start date to 2016.  Previously patient took first dose of BNT162B2 Injected intramuscularly in left arm on 01Mar2021. Patient stated he has 8 separate reactions since the second dose. Reported leg spasms, Severe back pain, chills and one episode of vomiting. Stated he was two months out and still getting them every 2 weeks. Reported that he was an incomplete quadriplegic since 1972. The dates as 25Mar2021, 30Mar2021, 04Apr2021, 05Apr2021 noting had the leg spasms, 06Apr2021 reported vomiting, 15Apr2021 had the fourth reaction that continued for 3 days noting they usually last 24 hours, 21Apr2021, 2May2021, 19May2021 and 21May2021. Patient stated he thought the frequency was getting longer up until last week. Wanted to know what type of doctor if any should he be talking to and if any-thing could be done other than taking Tylenol and if there have been reports of reactions continu-ally happening before. She received their first vaccine 01Mar2021, and second dose 22Mar2021, but was having same side effects 2 months out every 1 -2 weeks.  He was having leg spasms, severe back pain, and all kinds of side effects.  He was trying to figure out who can he talk to and how to manage these symptoms. Celebrex was the only thing he heard of that may have interacted.  He did not have a lot or expiration for that. NO ER or physician's office required. The outcome of the events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Pain, Pain in extremity
Clinical narrative: Arthritis pain in back, hips, shoulders and hands; Sore arm; He is not doing anything to cause the pain; This is a program spontaneous report from a contactable consumer or other non hcp (patient himself).  A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0185; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 19May2021 08:00AM as 1st dose, single for covid-19 immunization and would scheduled to receive the second dose on 10Jun2021.  The patient's medical history included bad Arthritis, Allergic to Penicillin from an unknown date. The patient's concomitant medication included Apixaban (ELIQUIS) 25mg tablets a day patient was taking blood thinner this since he was 48-year-old. On 19 May2021 after the vaccination the patient experienced with a Sore arm, on 20May2021 then the second day after the vaccination the arthritis started for no reason and had more pain in back, hips, shoulders and hands and prior to vaccine he would had minor pain here and there, every day, but now his arthritis had really flared up badly, had to take the pain medication every day. Patient stated that He was not doing anything to cause the pain. It had stayed the same since the pain started, since patient got the vaccination, his arthritis had been getting worse. could not take arthritis medications because he had 2 blood clots for that he was on blood thinners. Patient had a type of arthritis called DISH, which was in his back and was the worst rheumatoid arthritis and osteoarthritis a person can have. Patient was in a lot of pain and took just pain killers and pain medicine as treatment as prescribed Norco by his doctor, 7.5-325 tablets to take as needed. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event pain in back, hips, shoulders and hands was not recovered, and the other events was unknown.  Follow-up (24May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable 63-year-old male consumer (patient) reported that included patient weight, age, concomitant medication, treatment received, outcome of events.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product prescribing error
Clinical narrative: push out the second dose to 4 weeks,; This is a spontaneous report from a contactable consumer or other non hcp. A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 13May2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history included COVID-19 on Labor Day weekend, and she had antibodies 8 months later that were still present. The patient's concomitant medications were not reported. The patient experienced push out the second dose to 4 weeks. She states that they would like to have an appointment with the cardiologist prior to her receiving the second dose of the vaccine so she would like to know if they could push out the second dose to 4 weeks, on 11Jun2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain
Clinical narrative: has been experiencing chest and back pain; has been experiencing chest and back pain; This is a spontaneous report from a contactable consumer (patient himself). A 37-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0618) via an unspecified route of administration in left arm on 21May2021 12:00 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0173) via an unspecified route of administration in right arm on 30Apr2021 as 1st dose single for COVID-19 immunization. Patient experienced pain in right arm after the 1st dose of the vaccine on 30Mar2021 (as reported). Patient was 37-years-old at the time of immunization. Vaccination facility type was reported as Pharmacy/Drug Store. Vaccine was not administered at military facility. Patient medical history and concomitant medications were not reported. Patient had been experiencing chest and back pain. It had been 3 days now. He asked was that normal, how long will it last. Patient stated that he just got the second Pfizer vaccine shot and is experiencing chest pain (22May2021 at 24:00) and back pain (24May2021 at 24:00). Is wondering if this is normal. He stated that he got the first vaccine three weeks before on 30Apr2021. Patient describing about the adverse events stated that the chest pain is spreading into his back. Stated that the right arm pain lasted for four days and he recovered completely. The patient did not receive any treatment for the adverse events. The adverse events resulted in a visit to urgent care. The outcome of the events was not resolved.  Information on Lot/Batch number is available; Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait inability, Somnolence
Clinical narrative: Hard to wake up this morning; bad dizziness; unable to walk; This is a spontaneous report from a Pfizer sponsored program via medical information team. A contactable 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 21May2021, (75 years old at the time of vaccination) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23May2021, the patient experienced bad dizziness, unable to walk, hard to wake up this morning. It was reported that patient take several deep breaths to try and calm his dizziness. it was reported that patient received first dose 21May2021, experiencing bad dizziness and unable to walk. Asks "How long will this last?" and "Will it go away?". Indicates laying down currently. Declined further demographics. Potential duplicate AE. Reported that for a couple of days he was okay with no symptoms. Yesterday he didn't do anything. He stood up and sat right back down. His wife helped him but the dizziness got worse and worse. This morning he had a hard time waking up. States he did several deep breaths to try and calm his dizziness. Asks if this is regular? Is there anything he can do? Reported that patient thought he was being transferred to Medical Information. Declines to complete a report. he does not want to do anything else; he just wants information. States if symptoms persist he will go to his doctor. It was reported that reporter seriousness for Bad Dizziness, Unable to walk, Hard to wake up this morning was Unspecified. The outcome of all reported events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Breast pain, Chest discomfort, Musculoskeletal chest pain
Clinical narrative: felt like an anxiety attack that lasted almost 3 hours; pressure on my chest; pain on the side of my ribs; It got worst on the 3rd hour and was localized then right under my left breast; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 17May2021 at 13:15 (at the age of 37-years) as single dose for covid-19 immunization. The patient medical history included: known allergies Zytromax. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (Zyrtec Allergy), Bloom Protein powder, bloom collagen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 19May2021 at 21:00, the patient felt like an anxiety attack that lasted almost 3 hours. Patient had pressure on her chest and pain on the side of her ribs. It got worst on the 3rd hour and was localized then right under her left breast. The patient did not receive any treatment for events. Since the vaccination patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in May2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site extravasation
Clinical narrative: syringe malfunction and they had a loss of dose on the person's skin; syringe malfunction and they had a loss of dose on the person's skin; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a consumer (patient) that: A 47-years-old female patient started to receive first dose of bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine, solution for injection, Batch/Lot Number: EW0178; Expiration Date: Aug2021) via an unspecified route of administration on 24May2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24May2021, patient was given a shot of the COVID vaccine first dose and there may have been a syringe malfunction and they had a loss of dose on the person skin. The reporter considers the events as non-serious. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I had a delayed reaction and have a rash that's on my back; This is a spontaneous report from a contactable consumer(patient). A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 28Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2(BNT162b2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported) via unspecified route of administration as a single dose for COVID-19 immunization. The reported stated, 2 weeks after that, I had a delayed reaction and have a rash that's on my back. There was nothing else new that I changed, it was just really the vaccine on May2021. She reports concern and asks, I did see that delayed reactions can happen with the vaccine. I just wanted to confirm and how long and what I should do to treat it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: pounding headache; Body aches; Fever; Stiff neck and pain; This is a spontaneous report from a contactable consumer (patient). A 32-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 vaccine, Batch/Lot number: Unknown), via an unspecified route on an unknown date (Thursday) as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were unknown. On an unspecified date in May2021 (Thursday around 10:00), the patient experienced pounding headache and then she went home and later on that morning (around 15:00) patient had body aches, fever, and then the next day she had a stiff neck and pain/sore neck. It was unknown if the patient received any treatment for the events. The outcome of the pounding headache, body aches and fever was recovered in May2021 while for the stiff neck and pain was unknown.  Information about lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Epistaxis, Off label use, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Very strong nosebleed; Little pain in her shoulder; Inappropriate age at vaccine administration; off label use; unapproved population; This is a spontaneous report received from a contactable consumer(mother) or other non hcp. A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration in Arm Left on 19May2021 12:00 (at the age of 15-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks, prior to the vaccination and adverse event following prior vaccinations. Caller was a consumer (Consumer daughter) calling regarding the Pfizer Covid-19 vaccine and his daughter was the patient, who will be 16 in 2 months got the Covid-19 vaccine on Wednesday, 19May2021. Caller reported that the patient didn't feel anything bad other than a little pain in her shoulder. Next day on Saturday, 22May2021, the patient got a very strong nosebleed in the morning. Caller stated that he doesn't know if the patient's nose-bleed was related to the Covid-19 vaccination and maybe it's not related. Caller reported that the patient's second dose of the Covid-19 vaccine is already scheduled. Caller reported that the patient strongly believes that her nosebleed was not related to the Covid-19 vaccine. Caller stated that he does not know honestly if the Covid-19 vaccine was related to the patient's nosebleed, but he does not want the patient to get the second dose if she had this kind of reaction. Caller inquired what they should do. Caller didn't know the patient's exact weight. Caller declined to provide his address and that he did not have the patient's primary care physician's information. The patient experienced just slight pain in her shoulder later in the day on 19May2021. Caller reported that the patient was done after 2 days with the arm pain and patient got the nosebleed on the morning of Saturday, 22May2021. Caller reported that he doesn't remember the patient having any nosebleeds in the last 5 years. Patient's nose bled just the one time and nose stopped bleeding within half an hour and an hour later the patient felt fine. Caller reported that the patient's nosebleed was pretty bad. The whole sink was covered in blood from the patient's nose. Caller unable to provide product details for the patient's Covid-19 vaccine as he does not have the patient's vaccination information with him at time of call on 24May2021. The patient Didn't any AE(s) require a visit to Emergency Room and Physician Office. The outcome of the very strong nosebleed, little pain in shoulder was recovered and unknown for other events.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: been sick; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date as 1st single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient was sick. It was reported that the patient received the second dose on day 42 as she mentioned been sick as one of the reasons she could not get it on day 21. Patient was told she could receive the second dose of the Pfizer Covid 19 vaccine up to 42 days after the first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Throat tightness
Clinical narrative: heart was racing; throat getting a little tight; This is a spontaneous report received from a contactable pharmacist via a Pfizer- sponsored program  and Medical Information Team. A 26-year-old male patient received first dose of BNT162b2 (COMIRNATY, solution for injection, lot number: EW0153), via an unspecified route of administration on 26Apr2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. It was reported that, the patient got the first shot on 26Apr2021, instantly he's heart was racing and 5 minutes after he felt his throat getting a little tight, after 5 minutes still tight, 2-3 minutes it resolved on its own without any medication, no Benadryl and no medical assistance, he was okay after that. Patient confirmed that he did not experienced difficulty of breathing. The patient was advised to go to the doctor's office or hospital for the second shot in case he gets an anaphylaxis or worse reactions to the second dose. He states that the symptoms were resolved in about 2 minutes on the same day. The pharmacist was asking if these were considered as a severe allergic reaction and he wants to know if the patient should get the second dose or not. The outcome of the events heart was racing and throat getting a little tight was recovered on 26Apr2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: he had tiredness and a little headache.; he had tiredness and a little headache.; This is a spontaneous report from a contactable consumer (patient's wife). A 65-year-old male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 08May2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that she and her husband received the first dose of the vaccine on 08May2021. She mentioned her husband had a "small reaction" to the first dose and specified, he had tiredness and a little headache on an unknown date. She added their second dose was scheduled this coming Saturday and asked if their vaccination appointment could be changed to the previous day, Friday. No further details were provided due to disconnecting and the information documented was the only information that was provided by the medical information agent. Outcome of the events was unknown.  Information about lot/batch number is not available. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: today she is extremely nauseous; she developed severe stomach pain; This is a spontaneous report from a contactable consumer (patient's daughter). A 74-year-old female patient received BNT162b2(PFIZERBIONTECH COVID-19 VACCINE Solution for injection, Lot Number and Expiry date: Unknown) via an unspecified route of administration on 21May2021 as 2nd dose, single for COVID-19 immunization. Historical vaccination included BNT162b2 (Dose Number-1, Batch/lot number: EW0177 Anatomical Location-Left Arm) on 30Apr2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient daughter stated after received the second dose last Friday, 2 to 3 days later on 23May2021, her mother developed severe stomach pain last night and pain went away. On 24May2021, today she is extremely nauseous. The patient's daughter questioned that can a person develop side effects two to three days after getting the shot and stated otherwise her mother had food poisoning. The clinical outcome of the event stomach pain was recovered on 23May2021 and the event today she is extremely nauseous was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: He developed rash and fluid-filled blisters on one leg, which has then **extended to both arms**; He developed rash and fluid-filled blisters on one leg, which has then **extended to both arms**; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on 21May2021 as SINGLE DOSE, 2ND DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced he developed rash and fluid-filled blisters on one leg, which has then extended to both arms on an unspecified date, he developed rash and fluid-filled blisters on one leg, which has then extended to both arms on 22May2021. She explained since the following day, Saturday, he developed rash and fluid-filled blisters on one leg, which has then extended to both arms. She explained his symptoms are getting worst with time but is not severe. She described the blisters as: small, filled with liquid, some are appearing and disappearing and there are about ten of them. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event he developed rash and fluid-filled blisters on one leg, which has then extended to both arms was unknown and he developed rash and fluid-filled blisters on one leg, which has then extended to both arms with outcome of not recovered.  Follow-up attempts are needed. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chest pain, Dyspepsia, Vomiting
Clinical narrative: he says he was feeling like a heart burn/heart pain; pain in his upper chest/He says this primarily now this is like in his upper chest and throat and he is pointing to upper chest now.; he actually vomited yesterday. He feels like all day today.; he is in bed; This is a spontaneous report from a contactable consumer (parent) or other non-HCP. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0168, Expiration date: unknown) via an intramuscular route of administration in left arm on 17May2021 (age at vaccination 13-year-old) as first dose, 0.3 ml single for covid-19 immunisation. The patient medical history included ongoing depression and ongoing attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications included escitalopram oxalate (LEXAPRO) 15mg daily, methylphenidate hydrochloride (CONCERTA) 36mg daily, escitalopram 15mg daily and vitamins nos. Consumer reported that she has been reading about reports that young men have been having myocarditis after getting the Pfizer covid vaccine and her son, who received his first dose on 17May2021 began having symptoms like heartburn and pain in his upper chest on 23May2021, and now the pain was below his neck and he was hurting all day before the date of event reported  and on the day of report . Patient also threw up. On unspecified date patient was in bed. Patient said primarily now this was like in his upper chest and throat and he was pointing to upper chest now. consumer was watching a news with her husband on day of report (tonight), the story on a news about some heart information and young vaccine recipient and patient was 13 years old and consumer was trying to work out whether there was something the consumer need to go emergency room over. Consumer just did not know if this related to patient's never ever complained chest pain, so consumer was just worried about. Consumer was asking if patient's symptoms were due to heart inflammation. She asked if this was due to heart inflammation and asked if she should take him to the emergency room. Consumer reported that she just spoke with DSU to file a report, no reference number for that encounter. Reporter stated that she was working on prescription and there was NDC. Treatment included consumer just gave patient some pills same and omeprazole 20 milligram and set it on other to. She gave on the night before event reported (tonight) and on the day of report. The outcome of all events was unknown  Follow up #01 (24May2021): ):This is a follow up spontaneous report from a female consumer (patients mother) new information included suspect product detail, event detail, medical history, concomitant medication.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Joint stiffness, Nervousness, Somnolence
Clinical narrative: Still a bit nervous; Still little dizzy; Feel its almost kind of like being high or drunk like you just took a 'sip' or something, started to feel something; Jaw was kind of a little bit stiff; Sleepiness is a side effect; This is a spontaneous report from a contactable consumer (patient) submitted by India call centre. A- male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration on 23May2021 as unknown, single dose for covid-19 immunisation. Medical history included asthma. The patient's concomitant medication was not reported. On an unspecified date of May2021, the patient experienced still a bit nervous, still little dizzy at first, it gone away and feel it's almost kind of like being high or drunk like you just took a sip or something, started to feel something, jaw was kind of a little bit stiff and sleepiness is a side effect. Patient just needed a moment to calm down. patient is fine at the time of report. When confirmed if the consumer wanted to report this, patient stated, so sleepiness is a side effect, right, he is fine at the time of report, he dont have anything to report. When probed if the consumer has any medical query, patient stated, Well, he does have one, he was feeling bit dizzy but at the time of report he felt its almost kind of like being high or drunk like you just took a sip or something, started to feel something. No treatment was taken by the patient for the events. The outcome of the events was recovered on an unspecified date of May2021.  Information on Lot/Batch number was available. Additional information has been requested
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Contusion, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non healthcare professional (HCP). The patient reported for self.  A 41-years-old (non-pregnant) female patient received BNT162b2 (Formulation: Solution for injection; Lot Number and Expiration date: UNKNOWN) , via intramuscular route of administration on, Solution for injection) (reason for unknown Lot number: Unable to locate or read the details), via an unspecified route of administration on 30Apr2021 (at 41-years-old) as single dose for COVID-19 immunisation. Patient medical history included known allergies to Penicillin, Sulfa from an unknown date and unknown if ongoing. Concomitant medication (other medications the patient received within 2 weeks of vaccination) included estradiol (.025mg patch) taken for an unspecified indication, start and stop date were not reported. No other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 02-May2021 the patient experienced Bruising of legs, calf area. Severe throbbing in both legs, numbness and tingling in both feet and toes. No distal pulse in right foot. Anxiety, due to worry of health after the vaccine. The patient had been tested for COVID-19, underwent lab tests and procedures which included Nasal Swab test (sars-cov-2 test) result was negative on 06May2021. Patient underwent venous and arterial ultrasounds of unknown results. Therapeutic measures were taken for the events occurred. Events were reported as non-serious. The outcome of the events was reported as recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse absent, SARS-CoV-2 test, Ultrasound Doppler
Clinical narrative: This is a spontaneous report from a contactable consumer or other non healthcare professional (HCP). The patient reported for self.  A 41-years-old (non-pregnant) female patient received BNT162b2 (Formulation: Solution for injection; Lot Number and Expiration date: UNKNOWN) , via intramuscular route of administration on, Solution for injection) (reason for unknown Lot number: Unable to locate or read the details), via an unspecified route of administration on 30Apr2021 (at 41-years-old) as single dose for COVID-19 immunisation. Patient medical history included known allergies to Penicillin, Sulfa from an unknown date and unknown if ongoing. Concomitant medication (other medications the patient received within 2 weeks of vaccination) included estradiol (.025mg patch) taken for an unspecified indication, start and stop date were not reported. No other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 02-May2021 the patient experienced Bruising of legs, calf area. Severe throbbing in both legs, numbness and tingling in both feet and toes. No distal pulse in right foot. Anxiety, due to worry of health after the vaccine. The patient had been tested for COVID-19, underwent lab tests and procedures which included Nasal Swab test (sars-cov-2 test) result was negative on 06May2021. Patient underwent venous and arterial ultrasounds of unknown results. Therapeutic measures were taken for the events occurred. Events were reported as non-serious. The outcome of the events was reported as recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178 and Expiration date was not reported), via an unknown route of administration in right arm on 22May2021 at 12-12:30 PM as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0169 and Expiration date was not reported), via an unknown route of administration in right arm on 01May2021 as single dose for covid-19 immunisation. Patient had no problems with vaccines in past as kid or since she worked in emergency services. No issues with any previous vaccines. Patient had no adverse event following prior vaccination. The patient reported that, after receiving second dose of COVID- Vaccine on 22May2021 (on Saturday as reported). On 23May2021 (yesterday as reported) she noticed a lot of redness around the whole injection site and was knowing that pain and discomfort were normal. On 24May2021 (Today as reported), it was very noticeable with redness, it was hurting, itching and hot to touch. It was also hard. So it was hard, hot, red and itchy. She wanted to ask that, if they are side effects and also to know what she could do to help with them, what would be good to take care of it or she should just let it be or what. The outcome of events was not recovered.  Follow up attempts are needed; information about lot/batch number are provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178 and Expiration date was not reported), via an unknown route of administration in right arm on 22May2021 at 12-12:30 PM as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0169 and Expiration date was not reported), via an unknown route of administration in right arm on 01May2021 as single dose for covid-19 immunisation. Patient had no problems with vaccines in past as kid or since she worked in emergency services. No issues with any previous vaccines. Patient had no adverse event following prior vaccination. The patient reported that, after receiving second dose of COVID- Vaccine on 22May2021 (on Saturday as reported). On 23May2021 (yesterday as reported) she noticed a lot of redness around the whole injection site and was knowing that pain and discomfort were normal. On 24May2021 (Today as reported), it was very noticeable with redness, it was hurting, itching and hot to touch. It was also hard. So it was hard, hot, red and itchy. She wanted to ask that, if they are side effects and also to know what she could do to help with them, what would be good to take care of it or she should just let it be or what. The outcome of events was not recovered.  Follow up attempts are needed; information about lot/batch number are provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 38-years-old non-pregnant female patient received BNT162B2 first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0186) via an unspecified route of administration, administered in left arm on 23May2021 13:00 (at the age of 38-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Not Pregnant at time of Vaccination. Medical history included Blood clot and PE (pulmonary embolism). Patient had no known allergies. Concomitant medication(s) included Eliquis. On 24May2021 10:00, the patient experienced started a period/heavy spotting within 24 hours of vaccine after 13 days of previous period (on a 36 day cycle - period starts 23 days earlier than expected). Patient was not received any treatment. It was reported that most recent COVID-19 vaccine was administered at Pharmacy or Drug Store.  Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has been not tested for COVID-19. No covid prior vaccination and No covid tested post vaccination. Seriousness reported as non-serious. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.