chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Laboratory test, Urticaria, Urticaria chronic
Clinical narrative: Chronic urticaria; started out with hives; the vaccine may kick your immune system in to a hyperactive state; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported, Expiry Date: Not Provided) via an unspecified route of administration on Mar2021 as dose 1, single and dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on an unspecified date, the patient experienced chronic urticaria, started out with hives, the vaccine may kick your immune system in to a hyperactive state. The patient underwent lab tests and procedures which included laboratory test: unknown. The caller has done lots of test and they can't figure it out. NDC number of Pfizer covid vaccine was not provided. Investigation assessment was not provided. It was reported that the caller asked about possibility of chronic urticaria after the vaccine. She explained she was fine initially. Consumer is now reporting developing urticaria that began three months post vaccination series and is aware that the vaccine may kick immune system into a hyperactive state. The patient wanted to know if there has been any reporting of urticaria post vaccination. The caller did not provide age or demographic information. The patient gave appreciation to the team for helping with the information. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Hypersensitivity, SARS-CoV-2 test, Urticaria
Clinical narrative: Chronic urticaria; started out with hives; the vaccine may kick your immune system in to a hyperactive state; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported, Expiry Date: Not Provided) via an unspecified route of administration on Mar2021 as dose 1, single and dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on an unspecified date, the patient experienced chronic urticaria, started out with hives, the vaccine may kick your immune system in to a hyperactive state. The patient underwent lab tests and procedures which included laboratory test: unknown. The caller has done lots of test and they can't figure it out. NDC number of Pfizer covid vaccine was not provided. Investigation assessment was not provided. It was reported that the caller asked about possibility of chronic urticaria after the vaccine. She explained she was fine initially. Consumer is now reporting developing urticaria that began three months post vaccination series and is aware that the vaccine may kick immune system into a hyperactive state. The patient wanted to know if there has been any reporting of urticaria post vaccination. The caller did not provide age or demographic information. The patient gave appreciation to the team for helping with the information. The outcome of the events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Drug intolerance, Drug reaction with eosinophilia and systemic symptoms, Food intolerance
Clinical narrative: anaphylaxis/allergic reaction; Mast Cell Activation Syndrome; Drug Hypersensitivity Syndrome; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left at age of 47 years, not pregnant on 19Mar2021 14:00 (Lot Number: Pfizerep7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin prior to vaccine and traumatic brain injury from near fatal accident. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control; fluticasone propionate (XHANCE). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had an anaphylaxis/allergic reaction to the first Covid Pfizer vaccine shot, (her only shot) on 19Mar2021 and since then things had spiraled out of control with her body; many medications to treat had caused more anaphylaxis allergic reactions like Benadryl, Cromolyn and Famotidine/Pepcid (7meds in total as she had been on no new meds since). She presented with Mast Cell Activation Syndrome and Drug Hypersensitivity Syndrome. 5 ER visits, 2 hospital stays and no improvements. The only medications that seem to provide any relief. Hydroxyzine, Singulair and Prednisone and even with these medications she continue to have allergic reactions or intolerances to medications which has now expanded to food, exertion, scents, and temperature changes. Not sure why this was happening, as prior to 19Mar2021 no food allergies and never had anaphylaxis until then. Patient in need of treatment by a vaccine expert. Her body saw everything as a toxin. Adverse event started at 19Mar2021, 14:00, and resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalization for 7 days. This case was serious with seriousness criteria reported as life threatening and caused hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test via nasal swab on 12May2021 was negative. The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mast cell activation syndrome, SARS-CoV-2 test, Temperature intolerance
Clinical narrative: anaphylaxis/allergic reaction; Mast Cell Activation Syndrome; Drug Hypersensitivity Syndrome; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left at age of 47 years, not pregnant on 19Mar2021 14:00 (Lot Number: Pfizerep7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin prior to vaccine and traumatic brain injury from near fatal accident. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control; fluticasone propionate (XHANCE). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had an anaphylaxis/allergic reaction to the first Covid Pfizer vaccine shot, (her only shot) on 19Mar2021 and since then things had spiraled out of control with her body; many medications to treat had caused more anaphylaxis allergic reactions like Benadryl, Cromolyn and Famotidine/Pepcid (7meds in total as she had been on no new meds since). She presented with Mast Cell Activation Syndrome and Drug Hypersensitivity Syndrome. 5 ER visits, 2 hospital stays and no improvements. The only medications that seem to provide any relief. Hydroxyzine, Singulair and Prednisone and even with these medications she continue to have allergic reactions or intolerances to medications which has now expanded to food, exertion, scents, and temperature changes. Not sure why this was happening, as prior to 19Mar2021 no food allergies and never had anaphylaxis until then. Patient in need of treatment by a vaccine expert. Her body saw everything as a toxin. Adverse event started at 19Mar2021, 14:00, and resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalization for 7 days. This case was serious with seriousness criteria reported as life threatening and caused hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test via nasal swab on 12May2021 was negative. The outcome of the events was not recovered.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: little fever; This is a spontaneous report from a contactable consumer (patient himself). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196, Expiry date: Unknown), via an unspecified route of administration in Arm Left on 12Jul2021 17:30 (at the age of 41-years-old) as dose 2, single for COVID-19 immunisation. Medical history included Blood pressure high. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No prior vaccinations. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0217, Expiry date: Unknown) via an unspecified route of administration in Arm Left on 12Jul2021 17:30 as dose 1, single for COVID-19 immunisation and experienced no adverse event. Concomitant medication included ramipril (RAMIPRIL) taken for hypertension, started three years ago. On 13Jul2021, the patient experienced little fever. He wanted to know the temperature range of the body after receiving dose of the vaccine. Caller stated he know having this little bit of fever is kind of normal. Patient asked, what was the normal range of temperature. Stated the fever began a couple of hours ago today, 13Jul2021. He did not feel bad, just took his temperature and it was 100.5. The patient underwent lab tests and procedures which included temperature: 100.5 on unspecified date. No vaccine administered at Military Facility. The clinical outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient).  A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Jul2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he experienced some soreness in his arm right after the injection on an unspecified date in Jul2021, he said he was not worried about it. It was expected to be. His wife and son refused him to see his grandkids because they thought he would give them the COVID virus. Caller asked if that was possible. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: pain; reduced the range of motion of her left arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date (reported as 20Jan2021) at 05:15 PM (Lot Number: EL3302) as dose 1, single, via an unspecified route of administration, administered in left arm on an unspecified date (reported as 20Jan2021) (Lot Number: EM9810) as dose 2, single for COVID-19 immunization. Age at vaccination was unspecified, non-pregnant at time of vaccination. Medical history included high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine; colecalciferol (VIT D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 12:00 AM the patient was still experiencing pain which reduced the range of motion of her left arm. Seriousness criteria was reported as disabling/incapacitating. The events resulted in disability or permanent damage. No treatment was received. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: she developed rashes in both  arms; This is a spontaneous report received from a contactable consumer (patient) and from a Pfizer-sponsored program . A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: WAH363) via an unspecified route of administration in left arm on 21Jun2021 at 20:30 (age at vaccination 25-year-old) as dose 1, single for Covid-19 immunization at  Pharmacy/Drug Store. Patients medical history was none. Patients concomitant medications were not reported. Additional vaccines administered on same date of the pfizer suspect, prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and Adverse events following prior vaccinations was none. Caller had the 1st dose of the Pfizer COVID 19 vaccine last 21Jun2021 and afterwards on 26Jun2021 patient experienced rash on both arms, but mostly the right arm. She went to  on 13Jul2021 to have the 2nd dose and she was advised not to get it and should call us first due to the reaction she had from the 1st shot. She wanted to know if she can still get the 2nd dose. When asked about allergic reaction, she stated she had a rash in her arm after the first dose. Not sure if it is an adverse event or if she ate something she is allergic to. Adverse event did not result into emergency room visit and physicians office visit. The outcome of event was recovered on an unspecified date in Jun2021.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Mobility decreased, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Sars-COV-2; tested positive for Sars-COV-2; Felt terrible and hardly out of bed; Felt terrible and hardly out of bed; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 29Jan2021 08:00 (Batch/Lot number was not reported) as dose 2, single, via an unspecified route of administration, administered in arm on 08Jan2021 08:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Age at vaccination was 79-year-old. The patient medical history was none. Family medical history relevant to the events was none. Concomitant medications included hydrochlorothiazide, triamterene (TRIAMTEREEN/HYDROCHLOORTHIAZIDE) taken for blood pressure measurement; vitamin B12; ascorbic acid (VITAMIN C); colecalciferol (VITAMIN D 3); biotin. Prior Vaccinations (within 4 weeks) included: She got a flu shot, but she did not know the date of when she received it last. She did not remember whenever she got her shingles shot. It was two shots, that she got from Pharmacy. She thought she got the second shingles shot in Mar2021. She thought she got the first shingles shot six months before that (2020). Lot number and expiration date were unknown for both doses of the shingles shot. The patient experienced that she tested positive for Sars-COV-2 on 11Jul2021. She stated her symptoms consist of respiratory, a bad cold, chills. She felt terrible and hardly out of bed. She did not have fever. Coughing, cold. She walked three miles a day. The patient underwent lab tests and procedures which included Rapid covid test: negative on 11Jul2021, Send off covid test: positive on 11Jul2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, SARS-CoV-2 test
Clinical narrative: Low energy/weakness; loss appetite; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 15:30 (Batch/Lot Number: EN6202) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were other concomitant medications in two weeks. The patient experienced low energy/weakness, loss appetite on 05Mar2021. The events resulted in emergency room visit, and were serious per hospitalization and disability. The patient was hospitalized for low energy/weakness and loss appetite for 12 days. The patient underwent lab tests and procedures which included Nasal Swab (covid test): unknown results on an unspecified date.  Therapeutic measures were taken as a result of the events with Plasma exchange. The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: having redness and soreness on the arm of the injection site; having redness and soreness on the arm of the injection site; terrible pain, on the night he got the shot, he felt like his arm was coming off; terrible pain, on the night he got the shot, he felt like his arm was coming off; This is a spontaneous report from a contactable nurse. This nurse reported that a male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jun2021 as dose 1, single for COVID-19 immunisation. On 09Jul2021, the patient experienced having redness and soreness on the arm of the injection site and terrible pain, on the night he got the shot, he felt like his arm was coming off and the next day he was better. Asking if it will last for more than 3 days. The clinical outcome of events was unknown.  Information about lot and batch number was requested.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: About 3 to 4 days later, he started developing tingling of his face, precisely on his left side of the face; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received bnt162b2 (BioNTech COVID-19 vaccine; formulation: solution for injection; COVID Vaccine manufacturer: Unspecified; NDC number, UPC number, and Expiry Date: Unknown), dose 2 via an unspecified route of administration on 19Feb2021 (lot number: EL9269) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient historical vaccine includes bnt162b2 (BioNTech COVID-19 vaccine; lot number: not reported), dose 1 on 24Jan2021 as dose 1, single for Covid-19 immunisation. Consumer stated that the reason he called was because he just heard on the news with the Johnson and Johnson Covid vaccine that people were getting some tingling in their legs and he don't know if this was something that Pfizer knows about but four days of getting the second Covid vaccine from Pfizer, he had tingling in his face every day now and he reported that he received his second dose of the Pfizer BioNTech COVID-19 vaccine on 19Feb2021 and about 3 to 4 days later, he started developing tingling of his face, precisely on his left side of the face began sometime in Feb2021. He would like to know if this side effect has been reported with the Pfizer BioNTech COVID-19 vaccine. No PQC was reported. There is a medical information request. The outcome of the event was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Pulmonary oedema, SARS-CoV-2 test
Clinical narrative: fluid build up in lungs; Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer (patient).   A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 19Mar2021 15:30 (Lot Number: ERZ2613) at the age of 78-year-old as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had no COVID prior vaccination and had no allergies. The patient has other medication (unspecified) in two weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EN6202) on 26Feb2021 15:30 PM at the age of 78-year-old for covid-19 immunisation and experienced low energy, loss appetite & weakness 3 weeks after initial injection, although no pain in arm. In Mar2021, within the first week of the second shot, he was admitted to the hospital with fluid build up in the lungs. Within two weeks of his second injection he was diagnosed with Guillain-Barre syndrome. These events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient was in hospitalization for 12 days. The patient had COVID test type post vaccination: Nasal Swab with unknown results in 2021. The patient received plasma exchange for events. Outcome of events was recovering.    Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Poor quality product administered, Product storage error, Pyrexia
Clinical narrative: Cold; Sore throat; Fever; storage time in freezer exceeded; storage time in freezer exceeded; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer or other non-healthcare professional reported for a 14-year-old male patient (reporter's son). A 14-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), via an unspecified route of administration on 24Jun2021 (Batch/Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient's medical history included celiac disease. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced cold, sore throat and fever. It was reported that about 12-13 days later, the patient experienced a cold, sore throat and fever. Reporter asked if these symptoms have been reported. As per the reporter they have been notified that the Pfizer COVID-19 Vaccine that her 14-year-old son received was invalid due to storage time in freezer exceeded and a pharmacy staff member suggested that her son retake the vaccine. The reporter asked would storage over the recommended time decrease the efficacy of the Pfizer Covid 19 Vaccine. The outcome of the events was reported as unknown.  Information on Lot/Batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Migraine, Oligomenorrhoea
Clinical narrative: there were 50 days between her cycle in May and June, and then another 35 days between June and July; Her cycle had been notably worse as well, heavier bleeding and cramping as well as getting migraines; Her cycle had been notably worse as well, heavier bleeding and cramping as well as getting migraines; Her cycle had been notably worse as well, heavier bleeding and cramping as well as getting migraines; This is a spontaneous report from a contactable consumer. A 22-year-old non-pregnant female patient received BNT162B2 (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 13May2021 08:15 (at the age of 22-year-old) as single dose for covid-19 immunisation. Medical history and concomitant medications were none. No past drug event. 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 previously received first dose of BNT162B2 in arm left on 22Apr2021 08:00 for covid-19 immunisation and her menstrual cycle had been off since she got her first vaccine, but she didn't really notice it until after her second. Onset date reported as 09Jun2021, there were 50 days between her cycle in May and June, and then another 35 days between June and July. Her cycle had been notably worse as well, heavier bleeding and cramping as well as getting migraines frequently when on her period. This case was reported as non-serious. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Flare-ups of eczema; This is a spontaneous report based on the information received by Pfizer from another company. A contactable pharmacist reported for patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 2 via an unspecified route of administration on an unspecified date in Apr2021, as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient took previously BNT162B2, Dose 1, (Lot number and Expiry date was not reported) for COVID-19 Immunization. 2nd dose was about 3-4 weeks ago, on an unspecified date in 2021 patient has been having some flare-ups of eczema over past few weeks. However, he was working in a construction site in hot, sunny and dirty conditions. Pharmacist advised that they had a handful of patients report that 1-2 months after their 2nd dose of COVID Vaccines, their symptoms have flared up like the medication was no longer working (eczema, hives). In theory, the vaccines ramp up the immune system to build up protection against COVID. However, these COVID Vaccines seem to be pretty responsive which may be causing the immune system to really ramp up and causing flare-ups of the symptoms we are trying control with the meds. In theory, if this is what is happening, once the immune system calms back down, the med should be able to control the symptoms again. In general, for vaccines, the immune system is responsive for about 2-4 weeks. However, it seems like it may be longer for the COVID Vaccines. Pharmacist has had a couple patients report this to them about 1-4 months after the 2nd round of vaccine. So, if symptoms do not improve about 2 months after 2nd dose, follow up with md to see what he/she thinks. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Carbohydrate antigen 125 increased
Clinical narrative: elevated CA125; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via medical information team. A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date in Apr2021 as single dose for COVID-19 immunisation. Medical history included ovarian cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. The patient experienced elevated ca125 (carbohydrate antigen 125 increased) on an unspecified date. The patient had blood test and the patient was asking proteins cause elevated CA125. She indicates the concern as test results from protein. Indicates being sent for a PET scan. The outcome of event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy, Malaise, Neck mass, Pain
Clinical narrative: lump on her underneath her arms; on her neck, there was a lump there also; body was aching; she has a lump on her underneath her arms and lymph node swelling on the underarms and neck; Felt really sick; a little bit of fever; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Jul2021 as dose 1, single (at the age of 49 years) for COVID-19 immunisation. Medical history included having had the Covid virus before. The patient's concomitant medications were not reported. On 11Jul2021 (Sunday) in morning, the patient felt really sick and had a little bit of fever, body was aching and in afternoon, she had a lump on her underneath her arms and lymph node swelling on the underarms and also in her neck next to collarbone which began on Sunday. Then on 11Jul2021, she started feeling the lumps under the arm and on her neck, there was a lump there also. Patient further wanted to know if these were normal and if patient needs to go to the doctor. The outcome of events was unknown.  Information on lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lump on her underneath her arms; on her neck, there was a lump there also; body was aching; she has a lump on her underneath her arms and lymph node swelling on the underarms and neck; Felt really sick; a little bit of fever; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Jul2021 as dose 1, single (at the age of 49 years) for COVID-19 immunisation. Medical history included having had the Covid virus before. The patient's concomitant medications were not reported. On 11Jul2021 (Sunday) in morning, the patient felt really sick and had a little bit of fever, body was aching and in afternoon, she had a lump on her underneath her arms and lymph node swelling on the underarms and also in her neck next to collarbone which began on Sunday. Then on 11Jul2021, she started feeling the lumps under the arm and on her neck, there was a lump there also. Patient further wanted to know if these were normal and if patient needs to go to the doctor. The outcome of events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Streptococcal infection
Clinical narrative: patient having strep; This is a spontaneous report from a contactable consumer. A 15-year-old adolescent male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on 09Jun2021 as a Dose 1, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she was from Pediatrics and they have a patient who received the 1st dose of the Pfizer Biontech COVID-19 vaccine on 9Jun2021 and was due for the 2nd dose on 30Jun2021. However, they were not able to administer the 2nd dose due to the patient having strep. The reporter mentioned that the patient was taking antibiotics and that his doctor advised him not to get 2nd dose yet. The reporter said the patient came in today and wanted to know if he still qualified in receiving the 2nd shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased
Clinical narrative: I had a really fast rate which freaked me out so then I had an even faster heart rate; I feel it had a lot to do with anxiety but as well I've never had it spike that high with anxiety; This is a spontaneous report from a contactable consumer via Medical Information Team. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Enquired, warm transfer received from Pfizer agent withheld ( withheld, Reportum withheld). It was reported that, the caller was a consumer (25 years old, male) inquired about information regarding the side effects of the Pfizer Covid-19 vaccine. Stated that, the caller as understood, done some research recently and read that blood clots are a possibility as well as TTP. The caller stated that, there was too little information to rule anything in or out and was there anything else that caller may not have heard of. Stated that, the he had gotten the first vaccine, but he really didn't know whether he wanted to get the second one and it doesn't matter who its coming from. Stated that, he had a really fast rate which freaked him out so then he had an even faster heart rate. The caller questioned were the blood clots caused from the TTP or were those two symptoms separate. The caller stated that, he didn't know whether they have seen or can debunk this, but there was an study that showed it was linked to TTP. Stated that, he had all his questions answered and he will weigh the risks and rewards and see how he feel. The caller stated that, he thought, since this was already a symptom that has been expressed, he will not but he appreciate that and he will skip on documenting that. Stated that, he had a fast rate and then calmed himself down and brought his heart rate down, then it would spike back up when he was standing. Stated that, the patient felt it had a lot to do with anxiety but as well he have never had it spike that high with anxiety. The caller declined warm transfer. Response included was confirmed Pfizer Covid-19 vaccine. Provided disclaimers and referred caller to healthcare professional. Enquired, caller asked does the myocarditis happen minutes or hours after receiving the shot. The caller asked, was there anything else he need to know that he may not have heard of. Response included was referred to healthcare professional. The outcome of the events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Aspiration, Echocardiogram, Investigation, Myocarditis, Oxygen saturation
Clinical narrative: hospitalized for 1 week and had to be intubated due to aspiration; unresponsive. I did come and go speaking but made very little sense; inflammation of my heart; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnancy patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left upper arm on 28Apr2021 14:00 (Batch/Lot number was not reported, at age of 43 years old) as single dose for COVID-19 immunisation. Medical history included peripheral nueropathy and bipolar 2 and connective tissue disorder. The patient previously took amoxicillin and experienced drug allergies. Concomitant medications included unspecified medication received in two weeks. The patient was hospitalized for 1 week and had to be intubated due to aspiration. The patient's husband found her 4 days after her 2nd shot unresponsive. The patient did come and go speaking but made very little sense. Many tests were run with nothing found to explain and she also had an echo that confirmed inflammation of her heart. Event onset date reported as 02May2021 08:00 AM. Events resulted in Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalisation 7 days. The patient received treatment as Intibated, echo, O2, heart medication. The outcome of events was recovered with lasting effects.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: hospitalized for 1 week and had to be intubated due to aspiration; unresponsive. I did come and go speaking but made very little sense; inflammation of my heart; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnancy patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left upper arm on 28Apr2021 14:00 (Batch/Lot number was not reported, at age of 43 years old) as single dose for COVID-19 immunisation. Medical history included peripheral nueropathy and bipolar 2 and connective tissue disorder. The patient previously took amoxicillin and experienced drug allergies. Concomitant medications included unspecified medication received in two weeks. The patient was hospitalized for 1 week and had to be intubated due to aspiration. The patient's husband found her 4 days after her 2nd shot unresponsive. The patient did come and go speaking but made very little sense. Many tests were run with nothing found to explain and she also had an echo that confirmed inflammation of her heart. Event onset date reported as 02May2021 08:00 AM. Events resulted in Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalisation 7 days. The patient received treatment as Intibated, echo, O2, heart medication. The outcome of events was recovered with lasting effects.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache
Clinical narrative: bell's palsey; headache returned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient (not pregnant) received bnt162b2 (Pfizer, Batch/Lot Number: EW0173), second dose via an unspecified route of administration, administered in left arm on 22May2021 at the age of 58-year-old as dose 2, single for covid-19 immunization. Medical history included Hodgkins Lymphoma from an unknown date and unknown if ongoing. The patient previously took morphine and experienced allergies, first dose of bnt162b2 (Pfizer, Batch/Lot Number: EW0172) via an unspecified route, administered in left arm on 01May2021 at the age of 58-year-old for covid-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included: WOMEN'S ONE A DAY OVER 50. The patient experienced bell's palsey on 08Jun2021, headache returned/ headache on 23May2021. Onset of headache was 23May2021 which lasted until 27May2021 in back of head. Headache returned 03Jun2021 with no relief, so she went to the emergency department on 08Jun2021 and was diagnosed with bell's palsey. No prior history of nerological issues or disorders. Medication was provided and symptoms of bell's palsey went away by 22Jun2021. The event resulted in emergency room/department or urgent care visit. Therapeutic measures were taken as a result of events included empiric valacyclovir and prednisone, eye patching. The case was reported as non-serious. The outcome of events was resolved on 22Jun2021. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness
Clinical narrative: Extremely dizzy any time she moves her head or body was reported as worsened; Extremely dizzy any time she moves her head or body was reported as worsened; This is spontaneous report received from a contactable consumer (patient). A 25-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FA6780), dose 1 via an unspecified route of administration, administered in arm right on 08Jul2021 (at a age of 25-year-old) as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history was reported as none and patient's concomitant medications were not reported. The patient was just extremely dizzy any time she moves her head or body. It was just horrible. It started approximately a day and a half to 2 days after she had the shot. It was in the early morning she believes. The extremely dizzy any time she moves her head or body was reported as worsened on an unspecified date of 2021. No investigation assessment was present. No additional vaccines administered on same date of the Pfizer suspect. AE did not require a visit to emergency room and physician office. There was no prior vaccinations within 4 weeks and there was no AE(s) following prior vaccinations. The outcome of event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Today has itchiness and redness like a rash/ itching bad all over, pretty bad, and is getting red kind of; Today has itchiness and redness like a rash/ itching bad all over, pretty bad, and is getting red kind of; Today has itchiness and redness like a rash/ itching bad all over, pretty bad, and is getting red kind of; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on 12Jul2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and did not experience any adverse event. Caller was calling about the Pfizer Covid-19 Vaccine, he stated he was calling about his symptoms, he had his second dose of the COVID-19 vaccine on yesterday (12Jul2021) and today (13Jul2021) had itchiness and redness like a rash, like he read on the paper of things that could happen. He would like to know how to slow this down or stop this reaction and also reported that he was itching bad all over, pretty bad, and is getting red kind of. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling cold, Pharyngitis
Clinical narrative: She's been feeling cold (her body is feeling cold); Cough; Feels like her throat is inflamed; Has not been able to go to work; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 51-year-old), via an unspecified route of administration on 07Jul2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient had been feeling cold (her body is feeling cold). She has a cough and she feels like her throat is inflamed. She has not been able to go to work and now her company/employer is asking her for some papers from her doctor. She was wondering if she needs to book an appointment for that. So, she was referred her doctor. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Brain stent insertion, Intracranial aneurysm, Pain, Paralysis
Clinical narrative: almost paralyzed; caused terrible pain in her body for a week; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), first dose, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications includes: influenza vaccine on an unspecified date for immunization. The patient experienced almost paralyzed, and caused terrible pain in her body for a week on an unspecified date. The patient received a pneumonia vaccine years ago that caused a horrible reaction which almost paralyzed and caused terrible pain in her body for a week. She mentioned that she took it with the flu shot in which she only usually has a sore body from. It was the first time she has experienced that after getting her 1st Pneumonia shot. The outcome of the events was unknown. The patient also had a brain aneurysm and a brain stent put in on 28May2021. She had since been put on a blood thinner and was also taking asprin. She was wanting to know if it's safe for her to take the Covid vaccine.   Information about lot/batch number has been requested.  Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Erythema, Skin discolouration
Clinical narrative: discoloration of her arm; has problems with her brain; both her hands and palms were "beet red"; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer First Connect. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in right arm on an unspecified date at 12:00 (as per patient) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had received both doses of the Pfizer Covid-19 vaccine (unsure of dates, Spring or Summer) and after the first dose of vaccine both her hands and palms were "beet red", the first shot it was beet color she was describing it as, like beets, the vegetable, root, plant, reddish/purplish and both of her hands went red and it just spread through her blood and both of them became red. The patient experienced her arms were a strange red color and she has problems with her brain and she has discoloration of her arm and her arms and her palms, hands became a very red color, like beet root color. Patient informed it happened immediately after she was vaccinated. The patient informed that the vibrant color, the beet-root color was gone and she still has a little bit of redness, but its fine, she actually has it from "#", the redness. The patient has recovered and informed "no its not from the vaccination, the blood vessels, its a norm from her, its from school." The outcome of event erythema was recovered while the outcome of events problems with her brain and skin discoloration were unknown.  Information about Lot/Batch number has been requested.