chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Early vaginal bleeding; having some cramping; This is a spontaneous report from a contactable Other HCP. A 42-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported/ Unable to locate or read the details) via an unspecified route of administration in Arm left on 08Mar2021 10:15 as single dose for COVID-19 immunization. Medical history was not reported. Patient has no allergies. Concomitant medication included doxycycline (ORACEA) taken for an unspecified indication and GNC multivitamin received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. On 10Mar2021 19:30 early vaginal bleeding, have regular periods and now bleeding < 2 weeks after last period and around 17:30 had some cramp. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab-Pixel LabCorp): negative on 10Mar2021. Patient didn't receive any treatment for adverse event. Outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: post peri-menopausal heavy vaginal bleeding; This is a spontaneous report from a contactable consumer or other non-HCP. A 54-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left Arm on 26Feb2021 as DOSE 1, SINGLE (at the age of: 54-year-old) for covid-19 immunisation. Medical history included allergies in sulfa antibiotics, pennecillin, strawberries. No other vaccine was administered in four weeks. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. The patient's concomitant medications were not reported. On 06Mar2021 the patient experienced post peri-menopausal heavy vaginal bleeding. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; excruciating headache; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6199, Expiry date: 30Jun2021) via an unspecified route of administration on 04Mar2021 (at the age of 71-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Mar2021, the patient experienced excruciating headache and on 10Mar2021, she experienced vaginal bleeding. She does not think call handler can help, but she had the first dose of the shot and the side effects, aside from what was listed, she has excruciating headache, four to five days after the dose and bleeding, clarified to vaginal bleeding, like menstrual cycle. Both started a few days after the shot. She further clarified and said she got the first dose date of vaccine 04Mar2021 and 3 to 4 days after was when her headache started. She later clarified the excruciating headache started on 07Mar2021. She states the headache was still ongoing. Bleeding started yesterday morning. She states the bleeding was still ongoing. Caller states she will not do the second dose. She said it will kill her. She regrets that she did it because it was unproven. We only know what reactions are today but she does not know what is going to happen to her in the future. Besides it was so frightening. She said she was just rambling right now, maybe in a year or in the fall when they have new stuff coming out, she does not know but it was not proven. Outcome was not resolved for both the events.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Insomnia, Nausea
Clinical narrative: headache; nausea; chills/shivering; fever; sweating; body aches; unable to sleep due to body aches; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included kidney disease, recent surgery Jan2021 for brain aneurysm from Jan2021 (Other medical history), Penicillin (Known allergy: Penicillin) and COVID-19 (Covid prior vaccination). Concomitant medication included clopidogrel bisulfate (PLAVIX) and acetylsalicylic acid (ASPIRIN (E.C.) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient did not test covid post vaccination. Patient experienced headache, nausea, chills/shivering, fever, sweating, body aches, unable to sleep due to body aches, pain at injection site on 11Mar2021 02:30 AM. Patient did not received treatment for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: headache; nausea; chills/shivering; fever; sweating; body aches; unable to sleep due to body aches; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included kidney disease, recent surgery Jan2021 for brain aneurysm from Jan2021 (Other medical history), Penicillin (Known allergy: Penicillin) and COVID-19 (Covid prior vaccination). Concomitant medication included clopidogrel bisulfate (PLAVIX) and acetylsalicylic acid (ASPIRIN (E.C.) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient did not test covid post vaccination. Patient experienced headache, nausea, chills/shivering, fever, sweating, body aches, unable to sleep due to body aches, pain at injection site on 11Mar2021 02:30 AM. Patient did not received treatment for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Illness, Urticaria
Clinical narrative: allergic to it; hives; difficulty breathing; sick; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on 05Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic to it, hives, difficulty breathing and sick. It was reported that the patient was wondering how long would it take before the events comes out of her arm and she was wondering if she can take Mucinex or Benadryl. No unaddressed medical questions was referred or forwarded to Medical Information. Outcome of the event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain
Clinical narrative: Muscle pain in shoulder and lower neck on left side.; Muscle pain in shoulder and lower neck on left side.; Muscle pain in shoulder and lower neck on left side.; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in left arm on 13Mar2021 13:45 as single dose for COVID-19 immunization. Medical history included Post-concussion syndrome and crainiotomy. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone, levothyroxine sodium (LEVOXYL), sertraline hydrochloride (ZOLOFT), cefixime (FLEXERIL) and the patient received another unspecified medication. Patient previously took Ciprofloxacin and experienced with allergy. On 13Mar2021 14:00 patient stated that she was experienced with Muscle pain in shoulder and lower neck on left side. Patient received treatment was reported as no. Outcome of events was not recovered.  Information on the lot/ batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; fever; mild headache; body aches; This is a spontaneous report from a contactable other-HCP (patient herself). A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 12Mar2021 11:00 as dose number unknown single (at the age of 52-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. No other vaccine was administered in four weeks. Patient had no known allergies. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19 post vaccination. Patient medical history was reported as none. The concomitant medications were not reported. On 12Mar2021 at 16:00, patient experienced chills, fever, mild headache, and body aches. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the adverse events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blister, Herpes zoster
Clinical narrative: patient started with a terrible back pain same night after the vaccine around 23:00 later on a got a blister close to the bellybutton after 6 days of pain, patient was diagnosed with shingles.; patient started with a terrible back pain same night after the vaccine around 23:00 later on a got a blister close to the bellybutton after 6 days of pain, patient was diagnosed with shingles.; patient started with a terrible back pain same night after the vaccine around 23:00 later on a got a blister close to the bellybutton after 6 days of pain, patient was diagnosed with shingles.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left arm on 25Feb2021 11:00 (at the age of 44-year-old) as single dose for COVID-19 immunization workplace at Public Health Clinic/Veterans Administration facility. The patient medical history and concomitant medications were not reported. The patient had not any allergies. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The COVID-19 had not prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 25Feb2021 23:00, the patient experienced patient started with a terrible back pain same night after the vaccine around 23:00 later on a got a blister close to the bellybutton after 6 days of pain, patient was diagnosed with shingles. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received antiviral and pain medicine as treatment for the adverse events. The outcome of events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: spotting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:45 (48-years-old at the time of vaccination), (Lot Number: EN6206, expiry date not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included dexlansoprazole (DEXILANT); liraglutide (SAXENDA); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); colecalciferol (VD), Multi Vitamin taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 administered in Arm Left on 17Feb2021 10:00 AM (Lot number EL9266). Patient stated, that she have the Mirena IUD and have not had a period in years. Two days after receiving the vaccine, she was spotting on 12Mr2021 8:00 AM. Patient did not receive any treatment for the event. The clinical outcome of the event was Recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Vaginal Blood Spotting; This is a spontaneous report from a non-contactable consumer. A 27-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, in arm Left on 09Mar2021 at 15:30 (at the age of 27-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON), vitamin d nos, ascorbic acid vitamin c [ascorbic acid], fish oil and daily Multi (unspecified). On 11Mar2021 at 08:00, the patient experienced vaginal blood spotting. The patient received no other vaccine in four weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jan2021. Treatment was not given for the event. The patient tested covid post vaccination and covid test result was negative on 11Jan2021. Outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Rash
Clinical narrative: rash on stomach; unable to breathe; Coughing; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6207; Expiration Date: 31Jul2021; NDC number: unknown) via an unspecified route of administration on 12Mar2021 at 10:00 (at the age of 54-years-old) in left arm as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect, prior vaccinations (within 4 weeks) and additional vaccines administered on same date of the Pfizer suspect were reported as none. No investigation assessment was reported. The patient received covid-19 vaccine on 12Mar2021, she was fine and did not had any problems. On 14Mar2021 she was unable to breathe and was coughing. She took Benadryl and it helped. On 15Mar2021 she had a rash on stomach. It was not a big rash, there were 3 dots and it looked like a triangle. She was unsure if the rash was an insect bite or from the vaccine. The adverse event did not require emergency room or physician office visit. Relevant tests were not reported. The outcome of the event rash was not recovered and for all other events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Nodular fasciitis, Ultrasound scan
Clinical narrative: lump developed in injection arm 3 days after vaccine injection.  As of 1 week later, it has not gone away or gotten larger.  Diagnosed as possibly nodular fasciitis; lump developed in injection arm 3 days after vaccine injection.  As of 1 week later, it has not gone away or gotten larger.  Diagnosed as possibly nodular fasciitis; This is a spontaneous report from a non-contactable consumer. A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN 6205, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (age at vaccination 28 years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced lump developed in injection arm 3 days after vaccine injection. as of 1 week later, it has not gone away or gotten larger. diagnosed as possibly nodular fasciitis on an unspecified date. The patient underwent lab tests and procedures which included ultrasound scan with unknown results. Therapeutic measure were taken as a result of events which includes ultrasound, multiple doctor/surgeon visits. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration (at the age of 60-years), administered in arm right on 12Mar2021 08:45 as dose 1, single for COVID-19 immunization. Medical history included ongoing asthma and diagnosed over 20 years ago. Concomitant medications included sertraline hydrochloride (SERTRALIN [SERTRALINE HYDROCHLORIDE]) taken for anxiety from 03Mar2021 to 08Mar2021. On 12Mar2021, the patient experienced difficulty breathing. Patient received the first dose of the Covid-19 vaccine on 12Mar2021. She had asthma and thinks she could have had an asthma reaction and is following up. There were 20 steps or more to the waiting room. As she sat down she had diff breathing. She thought it could be asthma. She doesn't do well climbing stairs. The difficulty breathing subsided in a minute or two. She did not take off her N-95 mask though she wanted to in order to catch her breath. She did not have to use her rescue inhaler. She did not have it with her. She tends to worry and over reacts. She was due to get the second dose on 02Apr. She thinks this could have been a reaction, her family received the Pfizer vaccine and no one had any issues. Her sister said she was panicking. The difficulty breathing ended after one to two minutes. She had the second shingles vaccine on 28Jan2021. When providing concomitant medications, she started taking Sertraline HCL on 03Mar2021. It caused her to be more anxious. She was jittery and restless. She did not like how it made her feel. She called her doctor and he said she could stop. Product is filled in pharmacy bottle. NDC, Lot and Expiry are not listed. The doctor said this was common and it goes away in 2-3 weeks. She did not like how it felt and stopped. She wanted to rule out that something else wasn't going on. How does she know if its a side effect and what does she need to do about second dose? The adverse event does not resulted in emergency room and physician office visit. The patient was taking Covid-19 vaccine for Covid protection. Description of Product Complaint: taking Sertraline HCL caused more anxiousness, jitteriness and restlessness. Product strength and count size dispensed: Sertraline HCL 50mg . Additional lot numbers: NDC, Lot and Expiry are not on pharmacy bottle. Is a sample of the product available to be returned, if requested: Yes, caller will retain as a prepaid fedex mailer may be sent in 3-10 business days Packaging sealed and intact was not applicable. The outcome of the event was reported as recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspepsia, Nausea
Clinical narrative: a big loss of appetite for a few days; indigestion/stomach bug; nausea; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection and Lot Number: EL3247), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as single dose for COVID-19 immunization. Medical history included chronic Lyme disease and autoimmune issues. Concomitant medication included lamotrigine (LAMICTAL), lithium, retinol and clindamycin. On an unspecified date it was reported as patient was not sure if these symptoms are related to vaccine. After 5 days of first vaccine shot the patient experienced a big loss of appetite for a few days, followed by mild stomach bug symptoms for 10 days, indigestion and nausea on an unspecified date. The seriousness of the events was reported as non-serious. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: Itching; My Chest hurt and I had hard time breathing; My Chest hurt and I had hard time breathing; I was sweating very very bad; The muscles and the upper part of my legs hurts and still hurt; The muscles and the upper part of my legs hurts and still hurt; Very tired; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6199and expiry date 30-Jun-2021) via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12 Mar2021 around 8:00 in night, the site where she had the needle it started itching. The patient's chest hurted and patient had hard time breathing. Patient was sweating very very bad and the muscles and the upper part of my legs hurted and still hurt and just very tired. Patient was a cardiac patient so, do not know. The patient did not wanted to go through this again on the second shot. Consumer was informed about Pfizer Medical information department and was provided with the number. Further probing was not done, hence limited information was available over the call. The outcome of itching, breathing difficult, chest pain, sweating, very tired was unknown and muscle ache and leg pain was not recovered.  No follow-up attempts were possible. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Itching; My Chest hurt and I had hard time breathing; My Chest hurt and I had hard time breathing; I was sweating very very bad; The muscles and the upper part of my legs hurts and still hurt; The muscles and the upper part of my legs hurts and still hurt; Very tired; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6199and expiry date 30-Jun-2021) via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12 Mar2021 around 8:00 in night, the site where she had the needle it started itching. The patient's chest hurted and patient had hard time breathing. Patient was sweating very very bad and the muscles and the upper part of my legs hurted and still hurt and just very tired. Patient was a cardiac patient so, do not know. The patient did not wanted to go through this again on the second shot. Consumer was informed about Pfizer Medical information department and was provided with the number. Further probing was not done, hence limited information was available over the call. The outcome of itching, breathing difficult, chest pain, sweating, very tired was unknown and muscle ache and leg pain was not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Mouth haemorrhage
Clinical narrative: Blood coming in mouth; Pain in right arm at injection; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6203, patient was 67-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 08Mar2021 at 08:05 as single dose for COVID-19 immunisation/Prevention. Medical history included barrett's oesophagus. Concomitant medication(s) included omeprazole (OMEPRAZOLE, dose: 40 mg daily) taken for barrett's oesophagus from Jul2020 to an unspecified stop date. Reported that patient and his wife both received vaccine. He experienced having blood in his mouth and injection site pain. His wife had other symptoms which completed in separate report. There was no prescriber. The nurse that administered said it had to be in the shoulder joint. He is unable to confirm if given intramuscularly. His second dose is scheduled for 29Mar2021, at 7:55 am. He would like to know if the bleeding in mouth and nose have been reported before. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that blood coming in mouth in late evening. It was not a lot, but you could notice. Like some time when you take a high dose aspirin and blood gets thin like in nose or mouth. Very minor. He noticed 3-4 times and after 5 cold gargles it was better. He has not taken any aspiring, he right arm sore at injection side. 17:00-18:00 about 10 hours after receiving. On 10Mar2021, the patient experienced blood coming in mouth, on 08Mar2021, the patient experienced pain in right arm at injection. No ER or physician's office required. No prior Vaccinations within 4 weeks, no AE following prior vaccinations. The outcomes of events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Influenza like illness, Rash
Clinical narrative: Extreme dizziness; flu like symptoms; trouble breathing; rash on right side of body; This is a spontaneous report from a contactable consumer. This 29-year-old non-pregnant female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, batch number; unknown as obscured by other product labelling, NDC number, UPC number, expiry date; unknown) via an unspecified route of administration on 17Mar2021 at 13: 00 (1:00 pm) (age at vaccination 29-year-old) at right arm as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Past vaccine included first dose of BNT162B2, lot number; unknown on an unspecified date for covid-19 immunisation. Past drug event included known allergies to Sulfa drugs. 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. Patient's concomitant medication included Sertraline, Omeprazole for unknown indication. It was reported that, Patient experienced extreme dizziness and trouble breathing, flu like symptoms and rash on right side of body on 18Mar2021 at 12:00 am. AE resulted in none of the above. When probed for the concern, Reported that patiient received her second dose of Pfizer vaccine (unspecified vaccine) yesterday (17Mar2021) and she knew that flu like symptoms were common but she developed rash on the right part of her body. she received my dose in her right arm and she didn't know are these symptoms or not, she wanted want to know that right part of her body rash or was something concerning or it's common. When probed for event start date, consumer stated she got the shot at 1 o' Clock yesterday afternoon and I woke up at 12 am this morning with symptoms (18Mar2021). When probed for the vaccination facility name, consumer stated, no, Idea it was at clinic. As consumer abruptly hung up the call. Product details (LOT#, expiration date, NDC# and UPC#), Pharmacy details and further probing could not be done. Hence, limited information was available over the call and appropriate response could not be provided. It was unknown if the treatment was received for the adverse event. The patient has not been tested for COVID-19. The outcome of events was not recovered. Reporter seriousness for the events was unspecified.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: trouble breathing like there are something in her chest; trouble breathing like there are something in her chest; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. This consumer reported for a patient (Grandparent). This case is for grandparent 1. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported that grand daughter's grandparents had got the same vaccine and didn't experience reaction immediately. After sometime, they had trouble breathing like there are something in her chest on an unspecified date. And did not report the reactions. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021298909 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: trouble breathing like there are something in her chest; trouble breathing like there are something in her chest; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient.  A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown) via unspecified route, administered on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after the vaccination, the patient experienced trouble breathing like there are something in her chest. They didn't experience reaction immediately. And they did not report the reactions also. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021298908 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Feeling abnormal, Nausea
Clinical narrative: didn't feel good; diarrhea; nausea; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself) received via Pfizer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea, nausea, shortness of breath on an unspecified date in 2021; didn't feel good on 14Mar2021. Patient got the first shot yesterday 13Mar2021. Patient didn't feel good the night after. Patient experienced diarrhea, nausea and shortness of breath. Patient wants to know if it is normal or if she should see her doctor. Outcome of the events was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Mass
Clinical narrative: between her 2nd and 3rd finger she developed a  quarter size a bubble forming on the same hand that I got the vaccine between my second and third finger on the top of the skin; end of the fingers; burning sensation; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient, self-reporting). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203 and expiration date was not reported), via an unspecified route of administration on 06Mar2021 (at the age of 62 years) as dose 1, single for COVID-19 immunisation. Medical history included type 2 diabetic (Verbatim: Type 2 diabetic) and hypertension from an unknown date and unknown if ongoing (Verbatim: Blood pressure high). Concomitant medication(s) included metformin taken for type 2 diabetes mellitus, Olmesartan taken for hypertension and amlodipine taken for hypertension, start and stop date were not reported. Patient took the vaccine first dose on 06Mar2021 and had to wait 15 minutes in the recovery room to make sure everything was fine. The vaccine site was about a 10-minute drive from her home. Her daughter drove her home. After the nurse injected her she had a burning sensation within a couple of minutes in the left arm. Patient went with her parents. Nothing happened in the recovery room. Patient looked down at her left hand and between the second and third finger a bubble was forming on her hand. It was little at the time. Her daughter said to keep massaging her arm after the vaccine. Patient kept massaging it and went to bed. Patient had received a brochure form the vaccine site and tried for a week to get through, but two days ago she stayed up until 1AM and a pharmacist took all her information. He said for her to call back. It was a dime size right on top of left hand between the second and third finger. Patient was calling to let Pfizer know what was going on and find out what she should do as it looks like a bubble that would appear after you touch something hot. Patient took Tylenol twice. The outcome of the events was Unknown.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Tremor, Varicose vein
Clinical narrative: and a knot in between her buttocks at her coccyx bone/left side there is a bone that protruded /bone protruding in her lower back/ her botox there is something showing like a hard knot or a bone; Sensation from buttocks to feet that felt like trembles inside of her muscles/something from her buttock on the right side that ran down her leg; Varicose veins in both legs/ Varicose veins; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that a 74-years-old female patient (pregnant-unknown) received second dose of BNT162B2 (Pfizer COVID 19 vaccine, solution for injection, batch/lot number: EN6201, NDC/ expiry date: unknown), via an unspecified route of administration in left arm on 09Feb2021 (at the age of 74-years-old) at 13:00 as DOSE 2, SINGLE for COVID-19 immunisation. It was unknown if patient was pregnant or not at the time of vaccination.  The patient's medical history and concomitant medications were not reported. Additional vaccines administered on same date of the Pfizer suspect, patient medical history (including any illness at time of vaccination) and prior vaccinations (within 4 weeks) were none. The patient received first dose of BNT162B2 (Pfizer COVID 19 vaccine, solution for injection, batch/lot number: EL3249, NDC/ expiry date: unknown), via an unspecified route of administration in right arm on 18Jan2021 (at the time of vaccination 74-years-old) at 10: 00 as historical vaccination as DOSE 1, single for COVID-19 immunisation. On the second day after she had it, 11Feb2021 (2 days after vaccine), she was asleep in the bed, and she experienced a sensation from buttocks to feet that felt like trembles inside of her muscles/ something from her buttock on the right side that ran down her leg on the right side; it was so strong but just one time; and it woke her up. On 04Mar2021, a knot in between her buttocks at her coccyx bone/ left side there is a bone that is protruded/ bone protruding in her lower back/ her botox there is something showing like a hard knot or a bone. It was not there before. Adds two weeks before she had varicose veins in both legs (3-4 weeks after) in Feb2021; more so on the left side and not that many on the right side. Mentions that she did see her HCP about the appearance of the bone and he did x-rays but told it was old age. She was not happy with his examination. Seriousness not provided. The patient required a visit to physician or ER for adverse event. She did go to the doctor who did X rays; the doctor said it was old age. The outcome of adverse event something from her buttock on the right side that ran down her leg was recovered on 11Feb2021. The outcome of adverse events left side there is a bone that protruded and varicose veins was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 71-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9269), via an unspecified route of administration in the left arm on 06Feb2021 at 11:30 (at the age of 71 years old), as dose 1, single for COVID-19 immunisation. The patients medical history was reported as known allergies to narcotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On Feb2021, the patient experienced shortness of breath. It was unknown if patient received any treatment for the adverse event. The clinical outcome of the event shortness of breath was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021312093 Same reporter, patient/ similar events/ different dose
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: elevated heart rate-in the range of 90-170 while just sitting/not engaging in activity; sore throat with discomfort; sore throat with discomfort; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 08:15 (at the age of 28-year-old) as single dose for covid-19 immunisation. COVID-19 vaccine was administered at Public Health Clinic/Administration facility. Medical history included drug hypersensitivity to penicillin, amoxicillin. Concomitant medications included ethinylestradiol, norgestimate (TRI-LO-SPRINTEC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, the patient experienced elevated heart rate-in the range of 90-170 while just sitting/not engaging in activity, sore throat with discomfort. The patient underwent lab tests and procedures which included heart rate: elevated in the range of 90-170 on 18Mar2021, normal range of inactivity 65-75. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Pain
Clinical narrative: it felt like it wiped out all her medicines and made her feel like she had no ilaris in her; the entire body and joints were hurting; the entire body and joints were hurting; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (Reference ID: NVSC2021US040953_OS).  A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 15Mar2021 (Age at vaccination 64-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she had COVID vaccine yesterday and it felt like it wiped out all her medicines and made her feel like she had no ilaris in her. This occurred 5 hours after vaccine. Husband is an HCP who administered the vaccine, and the entire body and joints were hurting. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Headache, Malaise, Oxygen saturation
Clinical narrative: Headache; Fever; Stomachache; General malaise; Oxygen saturation decreased/ oxygen level was 96 then went down to 95, then 94, and then 93; feels real weak; This is a spontaneous report from a contactable consumers. A 65-year-old male patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route of administration in left arm (at the age of 65-year-old) on 16Mar2021 as single dose for COVID-19 immunisation. Medical history included open heart surgery from Apr2020 to an unknown date, hypertension from Apr2020 to an unknown date, Autonomic dysfunction from 1989 to an unknown date and COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. The patient did not had any other recent vaccinations or not started any new medications. The patient previously received first dose of bnt162b2, (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via unspecified route of administration (at the age of 65-year-old) on 23Feb2021 as single dose for COVID-19 immunisation. The patient experienced headache, fever, stomachache, general malaise, oxygen saturation decreased and feels real weak on Mar2021. The second dose was given yesterday and this morning he is having adverse reactions, and she would like to know what they can do to help him. She says he had a high fever, a stomachache, and a headache. She says his oxygen level was 96 then went down to 95, then 94, and then 93 on Mar2021. Patient says that his headache, fever, and stomachache are getting a bit better, but he had general malaise and feels real weak. He says he feels very bad like when he had COVID-19 this past Jan2021. He says that it was diagnosed with a deep swab, not the shallow one, in both nostrils and was a 24 hour test that was positive, it was not a rapid test. He says he had recovered from COVID-19. The patient underwent lab tests and procedures which included oxygen saturation: 95, oxygen saturation: 94, oxygen saturation: 96, oxygen saturation: 93 on Mar2021 and sars-cov-2 test: positive on Jan2021. The outcome of the events headache, fever, and stomachache was recovering and other events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; Fever; Stomachache; General malaise; Oxygen saturation decreased/ oxygen level was 96 then went down to 95, then 94, and then 93; feels real weak; This is a spontaneous report from a contactable consumers. A 65-year-old male patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route of administration in left arm (at the age of 65-year-old) on 16Mar2021 as single dose for COVID-19 immunisation. Medical history included open heart surgery from Apr2020 to an unknown date, hypertension from Apr2020 to an unknown date, Autonomic dysfunction from 1989 to an unknown date and COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. The patient did not had any other recent vaccinations or not started any new medications. The patient previously received first dose of bnt162b2, (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via unspecified route of administration (at the age of 65-year-old) on 23Feb2021 as single dose for COVID-19 immunisation. The patient experienced headache, fever, stomachache, general malaise, oxygen saturation decreased and feels real weak on Mar2021. The second dose was given yesterday and this morning he is having adverse reactions, and she would like to know what they can do to help him. She says he had a high fever, a stomachache, and a headache. She says his oxygen level was 96 then went down to 95, then 94, and then 93 on Mar2021. Patient says that his headache, fever, and stomachache are getting a bit better, but he had general malaise and feels real weak. He says he feels very bad like when he had COVID-19 this past Jan2021. He says that it was diagnosed with a deep swab, not the shallow one, in both nostrils and was a 24 hour test that was positive, it was not a rapid test. He says he had recovered from COVID-19. The patient underwent lab tests and procedures which included oxygen saturation: 95, oxygen saturation: 94, oxygen saturation: 96, oxygen saturation: 93 on Mar2021 and sars-cov-2 test: positive on Jan2021. The outcome of the events headache, fever, and stomachache was recovering and other events was unknown.   No follow-up attempts are possible. No further information is expected.