chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Memory impairment
Clinical narrative: stomach cramps; upset stomach; sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0153, Expiration date: Unknown), via an unspecified route of administration in arm left on an unspecified date (at the age of 61-year-old), as a single dose for COVID-19 immunisation. The patient medical history and family history was reported as none. The history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that she had the first shot three weeks before the second shot and had stomach cramps on an unspecified date at 06:00 and stated stomach would not settle down. The patient stated that last week on thursday, she was in downward spiral and could not get out of it and was being careful with what she ate. The patient had pain in lower abdomen that started 10 days ago and gets upset stomach from time to time but that it has been pretty constant since the first week in May. The patient stated that sometimes she remembers things that amazes her and sometimes she cannot remember what happened yesterday and Stated that other factors were involved (memory) at that time that her husband was ill. The event did not result in Emergency Room/Physician Office. The seriousness of all the events was unspecified. The relevant tests were reported as none. The patient received mylanta as treatment for the events. The outcome of stomach cramps was reported as resolved 10days after started, upset stomach as resolved with sequel and sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday as unknown.  Follow-Up is needed for furthur information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort
Clinical narrative: stomach cramps; upset stomach; sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0153, Expiration date: Unknown), via an unspecified route of administration in arm left on an unspecified date (at the age of 61-year-old), as a single dose for COVID-19 immunisation. The patient medical history and family history was reported as none. The history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that she had the first shot three weeks before the second shot and had stomach cramps on an unspecified date at 06:00 and stated stomach would not settle down. The patient stated that last week on thursday, she was in downward spiral and could not get out of it and was being careful with what she ate. The patient had pain in lower abdomen that started 10 days ago and gets upset stomach from time to time but that it has been pretty constant since the first week in May. The patient stated that sometimes she remembers things that amazes her and sometimes she cannot remember what happened yesterday and Stated that other factors were involved (memory) at that time that her husband was ill. The event did not result in Emergency Room/Physician Office. The seriousness of all the events was unspecified. The relevant tests were reported as none. The patient received mylanta as treatment for the events. The outcome of stomach cramps was reported as resolved 10days after started, upset stomach as resolved with sequel and sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday as unknown.  Follow-Up is needed for furthur information.
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: right leg is tight down near calf; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date are not provided), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that he had a schedule on 30May2021 for second dose appointment and did not expect them to be open and assumed they were closed. Stated technically speaking, he missed the second dose appointment. He also mentioned, was there any possibility that there would be a blood clot once he got the vaccine. He got it because he had to go to the doctor for something else and they scheduled him the appointment, he went over there and waited, waited, waited, and got an appointment, he got a paper and they said come back for second dose in 14 days. He stated that right leg right now was tight down near calf on an unspecified date in 2021 and he was noticing the last couple of days and said why was it so tight and that's all he was asking about. The outcome of the event was unknown.  Information on Lot/Batch number was not available. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hypoaesthesia, Magnetic resonance imaging, Pain
Clinical narrative: I still get odd pain in my head sometimes; My face got tingling and numb, and feel real cold inside; My face got tingling and numb, and feel real cold inside; My face got tingling and numb, and feel real cold inside; I got headache in front of my head towards left; after the second shot everything was worse; headache pattern has changed after the shot; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old female patient received BNT162B2 (BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN9581, expiration date unspecified), dose 1 via an unspecified route of administration, administered in Arm Right on 12Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included migraine from an unknown date. The patient's concomitant medications were not reported. On 12Feb2021, post vaccination the patient reported that her face got tingling and numb and feel real cold inside. Also, the patient had headache in front of my head towards left, after the second shot everything was worse, headache pattern has changed after the shot. The patient also experienced odd pain in head sometimes. On an unknown date, the patient had her MRI done and results were normal. The patient was treated with Tylenol and Imitrex from an unknown date. The outcome of the events was reported as not recovered (ongoing) at the time of report.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I still get odd pain in my head sometimes; My face got tingling and numb, and feel real cold inside; My face got tingling and numb, and feel real cold inside; My face got tingling and numb, and feel real cold inside; I got headache in front of my head towards left; after the second shot everything was worse; headache pattern has changed after the shot; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old female patient received BNT162B2 (BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN9581, expiration date unspecified), dose 1 via an unspecified route of administration, administered in Arm Right on 12Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included migraine from an unknown date. The patient's concomitant medications were not reported. On 12Feb2021, post vaccination the patient reported that her face got tingling and numb and feel real cold inside. Also, the patient had headache in front of my head towards left, after the second shot everything was worse, headache pattern has changed after the shot. The patient also experienced odd pain in head sometimes. On an unknown date, the patient had her MRI done and results were normal. The patient was treated with Tylenol and Imitrex from an unknown date. The outcome of the events was reported as not recovered (ongoing) at the time of report.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a contactable consumer (Patient).   A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number was not reported), via an unspecified route of administration, on an unspecified date, as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was tired and thought it was due to getting his COVID-19 vaccine. The outcome of the event was unknown.  Information about lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasopharyngitis, Pain
Clinical narrative: I feel little cold, I know that it's my eyes, my nose, my throat, my body hurts; I feel little cold, I know that it's my eyes, my nose, my throat, my body hurts; Really bad allergies; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not reported), dose 1 via an unspecified route of administration on an unspecified date in May2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient had like really bad allergies for the past few days, felt little cold, eyes, nose, throat, body hurts. Patient was supposed to go for the second vaccine on the day of reporting but had like really bad allergies so patient wanted to make sure if patient would do it anyway. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: headache; fever; This is a spontaneous report from a contactable consumer (patient) from Pfizer. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown), via an unspecified route in the Arm right on 18May2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN (E.C.)) at unknown dose daily for having some troubles with his heart (Has been taking this medication for about one month) and clonazepam (KLONOPIN), 7.5mg daily dose for mental care (Has been taking this medication for about one month). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown) via an unspecified route in the Arm right on 21Apr2021 as, single for COVID-19 immunisation. On 01Jun2021, the patient experienced headache and fever. The patient confirmed he was calling in regard to Pfizer covid-19 vaccine. The patient received his second dose of the vaccine on 18May2021. However, last night he experienced a lot of headaches and fever. The patient asked that if it was normal that he received second dose of Pfizer Covid Vaccine 2 weeks ago and he started having a headache and a fever. The patient reported his headache has completely went away, but stated it was kind of hard yesterday. He clarified the headache hit him hard. The patient confirmed the fever also started last night, and it also went away. The patient clarified the headache and fever began last night around 18:00 or 19:00, stated he checked temperature at 22:00 last night and it was 38 degrees Celsius and he took the temperature with the one they point at the head with the light. Stated he was unsure of the time the symptoms went way, just when he woke up. He did not do anything for the headache or fever. He just wanted to know if this was normal. Outcome of the events was reported as resolved on an unspecified date in Jun2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Magnetic resonance imaging, Paraesthesia
Clinical narrative: facial tingling on the right side of face, largely cheek bone to jaw bone and only to right side of face and to this day still with this sensation; This is a spontaneous report received from a contactable consumer (patient him-self). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and Lot Number: ER8729) via an unspecified route of administration in Arm Left on 13Apr2021 (at the age of 46-year-old) as single dose for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. It was reported as patient received his only dose on 13Apr2021 and about an hour after dose started facial tingling on the right side of face, largely cheek bone to jawbone and only to right side of face and to this day still with this sensation. Patient stated that some days pretty mild and some pretty severe. Not numbness but he has a feeling and has sensation and it hasn't left but states it is on his right side. He says some days are mild and other days more pronounced and it moves around face. Sometimes in cheek bone and other is jaw and always on the right side. Patient visited physician office. Lab data includes on 04May2021 he had tests and he was told that he didn't have any allergies. On 26May2021 he had MRI and he pretty much ruled out anything neurological. On an unspecified date he went through some tests a cause hasn't been identified as to why he is having symptoms. Outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: running fever/Temperature is 100.8; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 01Jun2021 09:30 as, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date (about four weeks ago as reported), as single dose for COVID-19 immunisation. Patient had the reactions. The patient had the Pfizer Shot on 01Jun2021 (yesterday) about 9:30 in the morning then she started running fever last night about 7 o'clock (01Jun2021). This morning (on 02Jun2021) her temperature was 100.8. This was the second time she has a reaction to this shot and last time was about four weeks ago, when she got her 1st shot. The outcome of event was unknown.   Information about lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling; This is a spontaneous report received from a contactable consumer. A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration in left shoulder muscle on 12May2021 13:25 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of vaccine. The patient received second dose of BNT162B2 in left shoulder muscle on 02Jun2021 (Batch/Lot Number: EP7533) for covid-19 immunisation. The patient experienced facial swelling approximately 5-7 days after the administration of first dose of the vaccine. She did not have a time and stated it was when she woke up throughout the day and lasted for a week being very obvious and it started residing a little. She still has it now. It was more on right side initially than left. Then it looked like generalized swelling of whole face. It has gone down and she still has generalized swelling on her face. She did not receive any medical treatment for this. Outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Has medical issues; This is a spontaneous report from a contactable consumer (Patient wife). A male patient of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had medical issues (as reported). Patient stated that she has her husband's Covid card in her purse. No further details provided by the reporter. The outcome of the event was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Musculoskeletal chest pain
Clinical narrative: Chest pain after she got first shot; chest has been really tight and it hurts; chest has been really tight and it hurts; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8736; Expiration Date: 20Jul2021) via an unspecified route of administration, administered in left upper arm on 21May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. It was reported that after she got the first shot, on 21May2021 she started having pains in her chest. It didn't last long. She didn't think anything about it at the time. Then she had more chest pains. It scared her. Since then her chest has been really tight and it hurts. Patient stated that she did not think she would get the second shot. She also stated The chest pain started right after/ Chest pain after she got first. Her chest felt really tight. No treatment for chest pain. She was taking any medications within 2 weeks before getting the vaccine, she said she was. Then she said that she was out of time and she needed to go.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle aches; This is a spontaneous report from a contactable consumer. This consumer (daughter) reported for a female patient (reporters mother) of unspecified age that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced muscle aches. When providing her own experience with regards to the Pfizer COVID vaccine, reporter stated that her mom told her that she had a few muscle aches for like 12 hours after her second dose of Pfizer. No investigation assessment provided. The clinical outcome for the event was unknown.  No further information was provided or obtained. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Get two bumps under each arm pit but they went away a couple days late,wants to report an additional benefit; This is a spontaneous report from a contactable consumer or other health care professional (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EL324), via an unspecified route of administration on 01Feb2021 (at the age of 51-years-old) as 1st dose, single case for covid-19 immunisation. Medical history included mammary duct ectasia (clogged breast duct under her right arm pit) from 1999. The patient's concomitant medications were not reported. Consumer stated that she was calling to report not an adverse event, just the opposite, wanted to report an additional benefit to the Pfizer Covid vaccine. Caller was a Pfizer employee and also she wanted to report that after she had her oldest daughter in 1999 she had a clogged breast duct under her right arm pit, and there has been a bump that comes and goes with her period under her right arm pit. Since then, saw a doctor many years ago and did so many tests, CT and ultrasounds, they were not concerned. Caller stated she had the first dose of the Pfizer Covid vaccine on 01Feb2021 and then looking at her past three periods the bump did not bothered her, it has not been an issue since the dose of the vaccine. The outcome of event was recovered in Feb2021.
Age: 0.83
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given the liquid part of Pentacel and not the powder part, no AE; Upon Internal review a signification amendment was performed on 04-Jun-2021, to change the product code of Pentacel from 242 to 520  Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional in the United States.  This case involves a 10 months and 2 weeks old female patient who was given 0.5 ml liquid part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Batch number: UJ349AAA and expiration date: 22-Jun-2021, DTAP-IPV- Lot: U6841AA, expiry date: 22-Jun-2021, and ActHib- Lot: UJ349AA, expiry: 22-Jun-2021) and not the powder part via intramuscular route in the left thigh for prophylactic vaccination on an unspecified date (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (same day latency).  No adverse event reported at the time of reporting.  The medical assistance (MA) stated the nurse gave the liquid part of Pentacel with the blue top and not the powder part with the green top, the ActHib. The Caller was asking what to do if they only gave the liquid part of Pentacel and not the powder. Can they mix it with anything other than 0.4% NaCl (sodium chloride), what about water or they have 0.7% NaCl, where do they get the 0.4% NaCl. Can Sanofi supply it and how much 0.4% NaCl will they have to use. The caller was told that since the liquid part was 0.5ml they will have to use that much to reconstitute the powder.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered a booster dose of Menactra that was expired by 5 days with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional via A (Reference number- 00617105) and transmitted to Sanofi on 26-Apr-2021. This case involves a 20-year old male patient who administered a booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was expired by 5 days (expired product administered) on 26-May-2021 (lot number: U6594AA and expiration date: 21-May-2021] at an booster dose of 0.5 ml once (total) via intramuscular route in the left deltoid for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination was not reported.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of Menactra with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from consumer /non-health professional via Medical Information (Reference number- 00617311) and transmitted to Sanofi on 26-Apr-2021.  This case involves a 24-year old female patient who administered an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered) on 26-May-2021 (lot number: U6576AA and expiration date: 04-Apr-2021] at an 0.5 ml once (total) dose via intramuscular route in the left deltoid for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination was not reported.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site; a circular bubble in the middle, the area was 15 cm in diameter at the injection site; itching at the injection site, the area was 15 cm in diameter at the injection site; redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site; Initial and additional information received on 27-May-2021 regarding an unsolicited valid non-serious case received from a physician (Contact specialty Pediatrics) via Medical Information  (Reference number- 00618803).  This case involves a five year old female patient who experienced redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction), while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included POLIO VACCINE for prophylactic vaccination on 25-May-2021 at the same visit.  On 25-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5765BA and expiry date: 28-Aug-2022) (Injection) via an unknown route in the left thigh for prophylactic vaccination.  On 25-MAY-2021, the patient developed a non-serious redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction), on same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was also reported description: Health Care Professional called to report DAPTACEL has been causing chemical reaction in four patients. The caller stated that she has had four patients that developed the same injection site reaction after a vaccination with Daptacel and Doctors nurse called back stating they would like a replacement. Three of the patient received the same lot number for sure, the caller was not sure about the fourth patient. She will send pictures of the reaction areas of all of these patients. Product used, Still using product: No  No laboratories details reported.  The patient was treated with BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] and cool compresses for all the events.  On an unknown date, the patient recovered from all the events after five days.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Diffuse hives, everywhere except for face.  Treated with cetirizine. Marked improvement of symptoms
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin test negative, Urticaria
Clinical narrative: Diffuse hives, everywhere except for face.  Treated with cetirizine. Marked improvement of symptoms
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angioedema, Erythema, Nausea
Clinical narrative: tinnitus and hearing loss both ears
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lip swelling, Peripheral swelling, Product administered at inappropriate site, Rash
Clinical narrative: tinnitus and hearing loss both ears
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Deafness, Tinnitus
Clinical narrative: tinnitus and hearing loss both ears
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Computerised tomogram, Injection site pain, Malaise, Musculoskeletal chest pain
Clinical narrative: Pulmonary embolism with infarction diagnosed 12 days after 2nd of 2 doses in Pfizer COVID-19 series.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Palpitations, Paraesthesia, Pulmonary embolism, Pulmonary infarction
Clinical narrative: Pulmonary embolism with infarction diagnosed 12 days after 2nd of 2 doses in Pfizer COVID-19 series.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Pulmonary embolism with infarction diagnosed 12 days after 2nd of 2 doses in Pfizer COVID-19 series.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Infarction, Pulmonary embolism
Clinical narrative: Pulmonary embolism with infarction diagnosed 12 days after 2nd of 2 doses in Pfizer COVID-19 series.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood disorder, Hypercoagulation, Pulmonary embolism, Pulmonary infarction, SARS-CoV-2 test
Clinical narrative: Pulmonary embolism with infarction diagnosed 12 days after 2nd of 2 doses in Pfizer COVID-19 series.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure abnormal, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient had his 1st. Moderna vaccine shot on May 4th. at 3 pm, he drove back to work at 3:30 pm, he fell on cement floor by standing on his feet after 3:30 pm and before 4 pm, he had severe head trauma that required to have two surgeries to remove his left and right side scalp to give room for his brain to swell, he was in ICU for 16 days, he is in hospital.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Mental status changes, Syncope, Unresponsive to stimuli
Clinical narrative: Patient had his 1st. Moderna vaccine shot on May 4th. at 3 pm, he drove back to work at 3:30 pm, he fell on cement floor by standing on his feet after 3:30 pm and before 4 pm, he had severe head trauma that required to have two surgeries to remove his left and right side scalp to give room for his brain to swell, he was in ICU for 16 days, he is in hospital.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Craniectomy, Fall, Head injury, Intensive care
Clinical narrative: Patient had his 1st. Moderna vaccine shot on May 4th. at 3 pm, he drove back to work at 3:30 pm, he fell on cement floor by standing on his feet after 3:30 pm and before 4 pm, he had severe head trauma that required to have two surgeries to remove his left and right side scalp to give room for his brain to swell, he was in ICU for 16 days, he is in hospital.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Contusion, Full blood count, Platelet count decreased, Rash
Clinical narrative: I received my second dose of the Pfizer / BioNTech COVID-19 vaccine on Tuesday, May 18, 2021 at 1:53pm EDT. Many of the "typical" or "expected" side effects commenced about 12 hours later, including chills, night sweats, a slight fever (99.5), and headache and lethargy the following day.   Nothing was particularly off-putting until the afternoon of Wednesday, May 19, 2021, when I noticed small red spots on my legs and feet. A Google search suggested petechiae and enough cause for me to go to a nearby urgent care clinic. The petechiae were present on both legs and feet (and eventually a few spots on my hands), though a little more pronounced on the left side (with one noteworthy cluster on my left leg). I had no apparent gum bleeding or bruising (maybe one bruise, but the urgent care doctor thought it was there beforehand).  The doctor at the urgent care clinic confirmed petechiae and ran stat blood work for return that night. At ~9pm EDT on Wednesday, May 19, 2021, I received a phone call from the urgent care's centralized lab informing me that my platelet count was 2 (10^3/uL) -- dangerously low, with risk of spontaneous bleeding and in the worst case scenario brain hemorrhage -- and my PTT was 55.6 seconds. They told me to report to an emergency room immediately, the nearest of Medical Center.  The diagnosis was eventually Immune Thrombocytopenia (ITP). Every physician I've encountered has felt that the occurrence one-day post-vaccination points to the vaccine as the cause. (For what it's worth, I do not think any of the doctors or nurses I encountered had never seen a platelet count so low. Most of them said as much.) My discharge papers officially note as the diagnoses: petechiae, thrombocytopenia, and adverse effect of vaccine.  I have included details related to my platelet count, treatment course, and other figures below (and am happy to provide corroborating information where appropriate). The doctors did not run any d-dimers, PF4 HIT ELISA, or fibrinogen tests, and no imaging was performed, presumably because I did not present with any signs of simultaneous clotting (e.g., TTP or VITT). They've also told me that my haptoglobin and hemoglobin levels were normal (see below), which I am told helps support the notion that there was / is no clotting or "red blood cell breakdown."  Search terms: decreased platelet count, immune thrombocytopenia, ITP, severely low platelet count, low platelets, petechiae, idiopathic thrombocytopenic purpura, immune thrombocytopenic purpura, vaccine-induced immune thrombocytopenia, vaccine-induced ITP
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Erythema, Pain, Platelet count decreased, Pyrexia
Clinical narrative: I received my second dose of the Pfizer / BioNTech COVID-19 vaccine on Tuesday, May 18, 2021 at 1:53pm EDT. Many of the "typical" or "expected" side effects commenced about 12 hours later, including chills, night sweats, a slight fever (99.5), and headache and lethargy the following day.   Nothing was particularly off-putting until the afternoon of Wednesday, May 19, 2021, when I noticed small red spots on my legs and feet. A Google search suggested petechiae and enough cause for me to go to a nearby urgent care clinic. The petechiae were present on both legs and feet (and eventually a few spots on my hands), though a little more pronounced on the left side (with one noteworthy cluster on my left leg). I had no apparent gum bleeding or bruising (maybe one bruise, but the urgent care doctor thought it was there beforehand).  The doctor at the urgent care clinic confirmed petechiae and ran stat blood work for return that night. At ~9pm EDT on Wednesday, May 19, 2021, I received a phone call from the urgent care's centralized lab informing me that my platelet count was 2 (10^3/uL) -- dangerously low, with risk of spontaneous bleeding and in the worst case scenario brain hemorrhage -- and my PTT was 55.6 seconds. They told me to report to an emergency room immediately, the nearest of Medical Center.  The diagnosis was eventually Immune Thrombocytopenia (ITP). Every physician I've encountered has felt that the occurrence one-day post-vaccination points to the vaccine as the cause. (For what it's worth, I do not think any of the doctors or nurses I encountered had never seen a platelet count so low. Most of them said as much.) My discharge papers officially note as the diagnoses: petechiae, thrombocytopenia, and adverse effect of vaccine.  I have included details related to my platelet count, treatment course, and other figures below (and am happy to provide corroborating information where appropriate). The doctors did not run any d-dimers, PF4 HIT ELISA, or fibrinogen tests, and no imaging was performed, presumably because I did not present with any signs of simultaneous clotting (e.g., TTP or VITT). They've also told me that my haptoglobin and hemoglobin levels were normal (see below), which I am told helps support the notion that there was / is no clotting or "red blood cell breakdown."  Search terms: decreased platelet count, immune thrombocytopenia, ITP, severely low platelet count, low platelets, petechiae, idiopathic thrombocytopenic purpura, immune thrombocytopenic purpura, vaccine-induced immune thrombocytopenia, vaccine-induced ITP
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event following immunisation, Chills, Haemoglobin normal, Haptoglobin normal, Headache
Clinical narrative: I received my second dose of the Pfizer / BioNTech COVID-19 vaccine on Tuesday, May 18, 2021 at 1:53pm EDT. Many of the "typical" or "expected" side effects commenced about 12 hours later, including chills, night sweats, a slight fever (99.5), and headache and lethargy the following day.   Nothing was particularly off-putting until the afternoon of Wednesday, May 19, 2021, when I noticed small red spots on my legs and feet. A Google search suggested petechiae and enough cause for me to go to a nearby urgent care clinic. The petechiae were present on both legs and feet (and eventually a few spots on my hands), though a little more pronounced on the left side (with one noteworthy cluster on my left leg). I had no apparent gum bleeding or bruising (maybe one bruise, but the urgent care doctor thought it was there beforehand).  The doctor at the urgent care clinic confirmed petechiae and ran stat blood work for return that night. At ~9pm EDT on Wednesday, May 19, 2021, I received a phone call from the urgent care's centralized lab informing me that my platelet count was 2 (10^3/uL) -- dangerously low, with risk of spontaneous bleeding and in the worst case scenario brain hemorrhage -- and my PTT was 55.6 seconds. They told me to report to an emergency room immediately, the nearest of Medical Center.  The diagnosis was eventually Immune Thrombocytopenia (ITP). Every physician I've encountered has felt that the occurrence one-day post-vaccination points to the vaccine as the cause. (For what it's worth, I do not think any of the doctors or nurses I encountered had never seen a platelet count so low. Most of them said as much.) My discharge papers officially note as the diagnoses: petechiae, thrombocytopenia, and adverse effect of vaccine.  I have included details related to my platelet count, treatment course, and other figures below (and am happy to provide corroborating information where appropriate). The doctors did not run any d-dimers, PF4 HIT ELISA, or fibrinogen tests, and no imaging was performed, presumably because I did not present with any signs of simultaneous clotting (e.g., TTP or VITT). They've also told me that my haptoglobin and hemoglobin levels were normal (see below), which I am told helps support the notion that there was / is no clotting or "red blood cell breakdown."  Search terms: decreased platelet count, immune thrombocytopenia, ITP, severely low platelet count, low platelets, petechiae, idiopathic thrombocytopenic purpura, immune thrombocytopenic purpura, vaccine-induced immune thrombocytopenia, vaccine-induced ITP
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Lethargy, Night sweats, Petechiae
Clinical narrative: I received my second dose of the Pfizer / BioNTech COVID-19 vaccine on Tuesday, May 18, 2021 at 1:53pm EDT. Many of the "typical" or "expected" side effects commenced about 12 hours later, including chills, night sweats, a slight fever (99.5), and headache and lethargy the following day.   Nothing was particularly off-putting until the afternoon of Wednesday, May 19, 2021, when I noticed small red spots on my legs and feet. A Google search suggested petechiae and enough cause for me to go to a nearby urgent care clinic. The petechiae were present on both legs and feet (and eventually a few spots on my hands), though a little more pronounced on the left side (with one noteworthy cluster on my left leg). I had no apparent gum bleeding or bruising (maybe one bruise, but the urgent care doctor thought it was there beforehand).  The doctor at the urgent care clinic confirmed petechiae and ran stat blood work for return that night. At ~9pm EDT on Wednesday, May 19, 2021, I received a phone call from the urgent care's centralized lab informing me that my platelet count was 2 (10^3/uL) -- dangerously low, with risk of spontaneous bleeding and in the worst case scenario brain hemorrhage -- and my PTT was 55.6 seconds. They told me to report to an emergency room immediately, the nearest of Medical Center.  The diagnosis was eventually Immune Thrombocytopenia (ITP). Every physician I've encountered has felt that the occurrence one-day post-vaccination points to the vaccine as the cause. (For what it's worth, I do not think any of the doctors or nurses I encountered had never seen a platelet count so low. Most of them said as much.) My discharge papers officially note as the diagnoses: petechiae, thrombocytopenia, and adverse effect of vaccine.  I have included details related to my platelet count, treatment course, and other figures below (and am happy to provide corroborating information where appropriate). The doctors did not run any d-dimers, PF4 HIT ELISA, or fibrinogen tests, and no imaging was performed, presumably because I did not present with any signs of simultaneous clotting (e.g., TTP or VITT). They've also told me that my haptoglobin and hemoglobin levels were normal (see below), which I am told helps support the notion that there was / is no clotting or "red blood cell breakdown."  Search terms: decreased platelet count, immune thrombocytopenia, ITP, severely low platelet count, low platelets, petechiae, idiopathic thrombocytopenic purpura, immune thrombocytopenic purpura, vaccine-induced immune thrombocytopenia, vaccine-induced ITP
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Platelet transfusion, Prothrombin time prolonged, Pyrexia, Thrombocytopenia
Clinical narrative: I received my second dose of the Pfizer / BioNTech COVID-19 vaccine on Tuesday, May 18, 2021 at 1:53pm EDT. Many of the "typical" or "expected" side effects commenced about 12 hours later, including chills, night sweats, a slight fever (99.5), and headache and lethargy the following day.   Nothing was particularly off-putting until the afternoon of Wednesday, May 19, 2021, when I noticed small red spots on my legs and feet. A Google search suggested petechiae and enough cause for me to go to a nearby urgent care clinic. The petechiae were present on both legs and feet (and eventually a few spots on my hands), though a little more pronounced on the left side (with one noteworthy cluster on my left leg). I had no apparent gum bleeding or bruising (maybe one bruise, but the urgent care doctor thought it was there beforehand).  The doctor at the urgent care clinic confirmed petechiae and ran stat blood work for return that night. At ~9pm EDT on Wednesday, May 19, 2021, I received a phone call from the urgent care's centralized lab informing me that my platelet count was 2 (10^3/uL) -- dangerously low, with risk of spontaneous bleeding and in the worst case scenario brain hemorrhage -- and my PTT was 55.6 seconds. They told me to report to an emergency room immediately, the nearest of Medical Center.  The diagnosis was eventually Immune Thrombocytopenia (ITP). Every physician I've encountered has felt that the occurrence one-day post-vaccination points to the vaccine as the cause. (For what it's worth, I do not think any of the doctors or nurses I encountered had never seen a platelet count so low. Most of them said as much.) My discharge papers officially note as the diagnoses: petechiae, thrombocytopenia, and adverse effect of vaccine.  I have included details related to my platelet count, treatment course, and other figures below (and am happy to provide corroborating information where appropriate). The doctors did not run any d-dimers, PF4 HIT ELISA, or fibrinogen tests, and no imaging was performed, presumably because I did not present with any signs of simultaneous clotting (e.g., TTP or VITT). They've also told me that my haptoglobin and hemoglobin levels were normal (see below), which I am told helps support the notion that there was / is no clotting or "red blood cell breakdown."  Search terms: decreased platelet count, immune thrombocytopenia, ITP, severely low platelet count, low platelets, petechiae, idiopathic thrombocytopenic purpura, immune thrombocytopenic purpura, vaccine-induced immune thrombocytopenia, vaccine-induced ITP