chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary congestion
Clinical narrative: Been staying with his girlfriends parents and the girlfriends father tested positive for COVID-19.; Has not been feeling well; Little chest congestion; Sore throat; Sinus pressure; Loose bowel but not diarrhea; This is a spontaneous report from a contactable consumer or other non hcp(patient).   A 43-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Sep2020 (at the age of 43-years-old) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history was and concomitant medications were not reported. The patient previously took BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2020 as DOSE1, SINGLE for covid 19 immunisation. On 14Jul2021, the patient experienced little chest congestion, sore throat, sinus pressure, loose bowel but not diarrhea, been staying with his girlfriends parents and the girlfriends father tested positive for covid-19, has not been feeling well. Reporter and his girlfriend had been staying with his girlfriend's parents and the girlfriend's father tested positive for COVID-19. He has not been feeling well. Reporter had sore throat and a little chest congestion today (sinus pressure, loose bowel but not diarrhea got this from the callback). Reporter got the self swab, and he wants information on the clinical trial in area so he can give them a call and see if he can get in and for someone to come and pick up his swab for the study and the center. The outcome of all the events was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; flu-like symptoms ; it wasn't getting better; This is a spontaneous report from a contactable consumer. A consumer reported for patient (daughter). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid, and flu-like symptoms; it wasn't getting better on an unspecified date. It was reported that reporter daughter and reporter went and got our first vaccination with the Pfizer last week Tuesday which was this 06Jul anyways, she started having like flu-like symptoms everything and it was not getting better and two days ago (Further clarification unknown) and she went to the urgent care and, she got tested for a COVID, well the result came back today and shows that she tested positive for COVID. Reporter asking question is we were both Scheduled to receive the second shot of second vaccination about the end of this month, which is the 27, can she well I am so far, I am COVID negative but if she, can she get the second shot or she has wait sometime before she can get the second shot since now, they are saying she has COVID. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on unknown date. Dates for she went to the urgent care: Unspecified. Reporter seriousness for events: Unspecified. The outcome of events was unknown. Information about batch/Lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test
Clinical narrative: Exposed to some people with COVID I think last night; took a Rapid COVID test this evening and she tested positive; Exposed to some people with COVID I think last night; took a Rapid COVID test this evening and she tested positive; Not feeling well; This is a spontaneous report from a contactable consumer (patient). A female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, Expiry Date: unknown) via an unspecified route of administration on 28Jan2021 as dose 1, single and received second dose of  bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via unspecified route of administration on 18Feb2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, patient was exposed to some people with COVID last night and took a rapid COVID test this evening and she was tested positive. Patient was also not feeling well. It was reported that patient received both dosages. It was reported that "She said she went to a friend's party all day on Saturday. She says, I went to my friends party all day Saturday and both she and her husband have it In another word, I think what she was trying to say is she went to a party Saturday and I think whoever has the party, that person and her husband had the COVID (Further clarification was unknown, hence split case was not made), then she said she just took a Rapid COVID test this evening and she tested positive and she is not feeling well. I don't know exactly what but she tell me that she had to rest. I don't know what exactly the other symptoms she is having as far as the COVID 'goes' but she definitely took a rapid test and tested positive. It was reported that there was product complaint. Lab test included rapid covid test on an unspecified date and result was positive (she has a COVID). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received two doses of Adacel 13 months apart, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (Reference number- 00683679) and transmitted to Sanofi on 15-Jul-2021.  This case involves a 12 year old female patient who received two doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] 13 months apart (Inappropriate schedule of product administration)  The patient's past vaccination(s) included ADACEL on 17-JUN-2020, MENACTRA in 2020 and GARDASIL in 2020 for prophylactic vaccination.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) (lot: U6920AB, expiry date:15-Apr-2022) for prophylactic vaccination.  On 14-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6900AA, expiry date: 18-Nov-2022) via unknown route in the right arm for prophylactic vaccination.  It was a case of an actual medication error due to Drug dose administration interval too short (latency: same day)  No adverse event was reported.  It was reported "Caller reports that a patient received ADACEL, MENACTRA & GARDASIL in 2020 and they received the same vaccines yesterday. Is there anything we should informed the parents about? Caller stated that she had to disconnected but will call us back. Health care professional (HCP) requested guidance on how to proceed when a patient received two doses of Adacel, approximately 13 months apart. She stated that the patient was vaccinated with Adacel on June 17, 2020, and received a dose of Adacel yesterday, July 14, 2021"  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 the 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: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: the patient was inadvertently administered a dose of Pentacel that had expired with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via medical information (Reference number- 00685292) and transmitted to Sanofi on 16-Jul-2021.  This case involves a 15-month-old male patient who inadvertently received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that had expired (expired product administered).  The patient had DTaP and polio vaccine doses as past vaccination.  Medical history, medical treatment and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, VARICELLA ZOSTER VACCINE (MMRV).  On 15-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ337AAA, expiry date: 05-Jul-2021] via an intramuscular route at the right thigh for prophylactic vaccination. (expired product administered) (Latency: on the same day)  It was a case of actual medication error due to expired vaccine used.   It was reported that, "Upon transfer, physician (MD) asked how to proceed if a patient was administered an expired dose of Pentacel. MD also asked for any safety information on giving an expired vaccine or repeating the dose. MD did not have available the number dose in the series that this Pentacel dose was to have been, because the patient was born overseas and just came here in June".  At the time of report, no adverse event reported.   Outcome of event was unknown.   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 the 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: TDAP
Symptoms: Multiple allergies
Clinical narrative: multiple allergies; Initial information regarding an unsolicited valid non-serious case was received from other health care professional (Lab manager) via Medical Information (Reference number- 00690017) and transmitted to Sanofi on 20-Jul-2021.  This case involved a female patient who experienced multiple allergies, while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing drug hypersensitivity (patient had reactions in the past to other vaccines).  Concomitant medications were not reported.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event, "multiple allergies", (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  It was reported that, "caller did not have any detail on the patient as far as specific allergens, nor did he have the details of the patient's reactions or to which vaccines she had reactions to".  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the event was unknown.  There would be no information available regarding batch number in this case.
Sex: U
Vaccine: HIBV
Symptoms: Death, Haemophilus infection
Clinical narrative: patient died from Haemophilus influenzae disease; Initial information regarding an unsolicited valid serious case was received from the physician via other health professional (MSL-medical science liaison) via medical information (Reference number- 00690240) and transmitted to Sanofi on 20-Jul-2021.  This case involves a nine-month-old patient (gender unspecified) who died from Haemophilus influenza disease (Haemophilus infection), after patient received HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment, vaccination, family history and concomitant medications were not reported.  On an unknown date, the patient received a third dose of suspect HIB (PRP/T) VACCINE [strength: 0.5 mL, lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a serious Haemophilus influenza disease (Haemophilus infection), (unknown latency) following the administration of HIB (PRP/T) VACCINE. This event was assessed as medically significant and was leading to death.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment before death for the event (Haemophilus influenza disease).  It was reported that, no autopsy was done.   On 15-Jul-2021 (the last Thursday), the patient died due to Haemophilus infection (cause of death was reported as Haemophilus influenza infection).  Information on the batch number was requested.; Sender's Comments: This case involves a nine-month-old patient (gender unspecified) who died from Haemophilus infection (unspecified disease type and serotype), after third dose vaccination with ACT-HIB. The time to onset is unknown. There is no information regarding pre-exiting or undergoing medical conditions during vaccination, previous vaccination and tolerance, laboratory investigations ruling out alternate etiologies. No laboratory confirmation. Also, no autopsy was performed. Based upon reported information, role of suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Haemophilus influenzae disease
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Severe Pain in left elbow, painful to move, painful to touch. Then swelling began spreading up and down arm from either side of elbow.  Eventually swelling was up to shoulder and down to fingers.  Shot was administered in left arm with only minor pain near injection site for 1st couple of days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Ultrasound scan normal, X-ray limb normal
Clinical narrative: Severe Pain in left elbow, painful to move, painful to touch. Then swelling began spreading up and down arm from either side of elbow.  Eventually swelling was up to shoulder and down to fingers.  Shot was administered in left arm with only minor pain near injection site for 1st couple of days.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery occlusion, Vascular graft
Clinical narrative: Massive coronary blockage. Required emergency triple bypass surgery. Had no previous reports or labs of any kind of issues. Excellent numbers in BP and cholesterol before and after event.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Aphonia, Dysphonia, Nasopharyngitis, Secretion discharge
Clinical narrative: Since April and continuing thru today July 24, 2021, loss of taste completely in mouth, loss of voice from partial hoarse to complete loss continuous cold, sinus and mucous; No one so far has decision on what is causing all these issues
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus disorder
Clinical narrative: Since April and continuing thru today July 24, 2021, loss of taste completely in mouth, loss of voice from partial hoarse to complete loss continuous cold, sinus and mucous; No one so far has decision on what is causing all these issues
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Migraine, Nausea, Pain
Clinical narrative: Fullbody aches and fatigue - ongoing Migraine - ongoing Nausea - ongoing
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood magnesium normal, Blood potassium decreased, Diarrhoea, Muscular weakness, White blood cell count increased
Clinical narrative: Patient had diarrhea that started about half a day after the vaccine was received (7/22/21). He presented to the emergency department 7/24/21 with chief complaint of diarrhea and bilateral lower extremity weakness.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperventilation, Lethargy, Somnolence
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hyperventilation-Medium, Additional Details: Patient complained of sleepiness, lightheadedness and we contacted rescue at the parents request
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fall, Feeling cold, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: At the time I was administering another COVID vaccination, and heard the patient fall on the floor upon which I noticed he was lying flat on the ground not responsive. I had one of the customers call 911 and assessed his vitals, he was breathing and conscious and speaking. He told me he still had trouble breathing and he felt very cold. By the time the paramedics arrived on the seen and helped the patient sit up on the chair he was feeling better. He was taken to emergency services soon after
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: At the time I was administering another COVID vaccination, and heard the patient fall on the floor upon which I noticed he was lying flat on the ground not responsive. I had one of the customers call 911 and assessed his vitals, he was breathing and conscious and speaking. He told me he still had trouble breathing and he felt very cold. By the time the paramedics arrived on the seen and helped the patient sit up on the chair he was feeling better. He was taken to emergency services soon after
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Tinnitus
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chest discomfort, Chest pain, Chills
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: nausea, vomiting and diarrhea lasted about 2 days, rash at injection site and fatigue present at 14 days post injection.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Fatigue, Flushing
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: nausea, vomiting and diarrhea lasted about 2 days, rash at injection site and fatigue present at 14 days post injection.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: nausea, vomiting and diarrhea lasted about 2 days, rash at injection site and fatigue present at 14 days post injection.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Lethargy, Nausea, Pain
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: nausea, vomiting and diarrhea lasted about 2 days, rash at injection site and fatigue present at 14 days post injection.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Tremor, Vomiting
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: nausea, vomiting and diarrhea lasted about 2 days, rash at injection site and fatigue present at 14 days post injection.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Migraine, Myalgia
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Mild, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Additional Details: Patient was vaccinated 7/18 and called on 7/23. Patient has had side effects of uncontrollable headache/migraines, muscle aches, general pain, periodic chills, night time fever, & nausea/vomitting (has not been ablel to keep food down). Symptoms have not gone away or gotten better
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Mild, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Additional Details: Patient was vaccinated 7/18 and called on 7/23. Patient has had side effects of uncontrollable headache/migraines, muscle aches, general pain, periodic chills, night time fever, & nausea/vomitting (has not been ablel to keep food down). Symptoms have not gone away or gotten better
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Systemic: Tinnitus-Medium, Additional Details: patient says symptoms are moderate during the day, but severe when sleeping. in addition to being diagnosed by audiologist, patient was also seen by a covid doctr.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Vision blurred, Visual impairment
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: After receivig vaccine, patient felt lighthead, blurry vision. Mother said she has a fear of needles and had not eating anything proior vaccine. SShe had some apple juice and ems came and check her out and was fine. did not go to hospital
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: patient felt lightheaded & dizzy ~15 min after receiving the Pfizer vaccine.  She was asked to have a seat & fainted.  Patient was responsive when spoken to & was kept under observation. She was given water, an ice pack, & snack while her feet was kept elevated while she was seated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site pain, Lethargy
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Mild, Systemic: Weakness-Severe
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Mild, Systemic: Weakness-Severe
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dizziness, Fall, Head injury
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Patient fell and hit his head on a pole which resulted in minor cut-Medium, Additional Details: Patient was in line to pick up a prescription after recieving 2nd dose of moderna, became dizzy/lightheaded. Patient fell and hit his head on a pole and had a minor cut that bled a little. 911 was contacted. NP from medical facility measured patient's BP, HR and O2 which were all normal. Paramedics indicated also normal vitals but with low blood sugar. Patient stated he had not eaten all day and had a history of seizures 8 years ago for which he is not taking any medication.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Vomiting-Medium, Additional Details: after 15mins pt vomited while walking out of store. she came back and stated she felt dizzy she was very pale. b/p was 88/86 pulse 107. had pt sit for 5 more mins. went out again and bp was 89/79 pulse 95. contacted ambulance as pt still felt faint. ambulance came 15 mins later. by that time pt had drank a whole bottle of water. pts vitals were within range. emts recommended she seek a physicians help at urgent care.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pallor, Tachycardia, Tremor, Vomiting
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Vomiting-Medium, Additional Details: after 15mins pt vomited while walking out of store. she came back and stated she felt dizzy she was very pale. b/p was 88/86 pulse 107. had pt sit for 5 more mins. went out again and bp was 89/79 pulse 95. contacted ambulance as pt still felt faint. ambulance came 15 mins later. by that time pt had drank a whole bottle of water. pts vitals were within range. emts recommended she seek a physicians help at urgent care.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Sore arm - muscle just below injection site when raising arm.  Started within couple hours after injection, continues into day  2. Ongoing  Extreme fatigue  - slept for ~12 hours within an hour of onset of sore arm.  Continued fatigue into day 2.  Overall lack of energy and tire easily. Ongoing
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Called Clinic provider, to assist. They administered oral benadryl and suggested calling EMS, but patient declined. Husband did drive patient to emergency room. Followup unknown
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury, Skin abrasion, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: After adminstration during obeservation period, patient briefly fainted fell from chair and scraped head slightly. Patient sat up on own back into chair, gave some water and did some deep breathes to help relax. Continued to observe no further symptoms, patient was anxious before adminstration.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Medium
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Nausea
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, Diarrhea, Heart Burn. Heartburn. Diarrhea beginning Saturday, July 24 around 6:30 AM.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: Pericarditis, moderate to severe chest pain, treated with 200mg Ibuprofen TID, currently out of work due to continued nausea, headaches and feeling light headed.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Nausea, Pericarditis
Clinical narrative: Pericarditis, moderate to severe chest pain, treated with 200mg Ibuprofen TID, currently out of work due to continued nausea, headaches and feeling light headed.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Appendicectomy, Appendicitis, Complicated appendicitis, Computerised tomogram abdomen abnormal
Clinical narrative: Adverse Event: Appendicitis Treatment: Appendectomy Outcome: Symptoms devolved 07/16/21. Presented to ER on 07/17/21, CT confirmed acutely inflammed non-perforated appendicitis. Laparoscopic appendectomy performed 07/17/21. Hospital discharge 07/18/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram pelvis abnormal, Laparoscopic surgery, Scan with contrast abnormal, White blood cell count increased
Clinical narrative: Adverse Event: Appendicitis Treatment: Appendectomy Outcome: Symptoms devolved 07/16/21. Presented to ER on 07/17/21, CT confirmed acutely inflammed non-perforated appendicitis. Laparoscopic appendectomy performed 07/17/21. Hospital discharge 07/18/21.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site warmth, Pain
Clinical narrative: hot at injection sight for two plus days.   After a few hours, began to feel tired and body aches for 1-1/2 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills, fever, 100 degrees, muscle aches
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Investigation, Pericarditis
Clinical narrative: Initial problem  2/8/21 pericarditis. Hospitalized 2 days. Started on colchicine, metoprolol and rosuvastatin, pain medications. EC 4/12/21 for DVT; Admit 4/16/21 for worsening DVT in right leg.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm, Vaccination complication
Clinical narrative: Covid Arm,  1-week large red swollen arm, warm to the touch size of a baseball.  Also body aches for two days.   this was second shot, first was on 1/27/2021   Since this reaction, I had another vaccination I reported, where I ended up with similar response, it was my shingles vaccination in July of 2021.  warm arm and body aches.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache, Hypotension
Clinical narrative: 1 day after receiving the COVID #2 vaccine, felt dizzy, body weakness, pain in stomach and head, fever (tactile), 1x vomit - food contents, blood pressure low (unable to recall).
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: 1 day after receiving the COVID #2 vaccine, felt dizzy, body weakness, pain in stomach and head, fever (tactile), 1x vomit - food contents, blood pressure low (unable to recall).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Chills, Fever, Headache, Joint Pain, Body Aches, Tiredness, Some Nausea
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chills, Fever, Headache, Joint Pain, Body Aches, Tiredness, Some Nausea
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High Blood pressure.    Referred to Pediatric Cardiologist
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dosage of 1.0mL given to 18yo when pediatric dose of 0.5ml should have been given. However pt will be "adult" and 19yo when he returns for second dosage. Pt informed of this via phone. No adverse reaction reported by pt at this time.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Basophil count decreased, Basophil percentage
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride increased
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood folate normal, Blood glucose normal
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G normal, Blood lactate dehydrogenase increased, Blood magnesium increased, Blood osmolarity decreased, Blood potassium normal
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium normal, Blood thyroid stimulating hormone normal, Blood triglycerides normal, Blood urea nitrogen/creatinine ratio, Blood urea normal
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Borrelia test positive, C-reactive protein decreased, Carbon dioxide normal, Eosinophil count decreased, Eosinophil percentage
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Gamma-glutamyltransferase normal, Glomerular filtration rate normal, Glycosylated haemoglobin normal
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, High density lipoprotein decreased, Hypoaesthesia, Immature granulocyte count
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: LDL/HDL ratio, Low density lipoprotein normal, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume normal, Monocyte count decreased, Monocyte percentage increased
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Neutrophil count normal, Neutrophil percentage decreased, Pain, Pain in extremity
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count normal, Protein total normal, Red blood cell count decreased, Red blood cell nucleated morphology, Red blood cell sedimentation rate normal
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Red cell distribution width normal, Thyroxine free normal, Very low density lipoprotein normal, Vitamin B12 normal, White blood cell count normal
Clinical narrative: Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram normal, Immunoglobulin therapy, Pyrexia
Clinical narrative: Patient had fever the day after the of receipt of the vaccine (on 7/18)  but then on 7/20 started to complain of mid sternal chest pain which lasted that day. He was evaluated in the ER and based on labs and history, admitted for evaluation. His chest pain had resolved by the following day.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Patient had fever the day after the of receipt of the vaccine (on 7/18)  but then on 7/20 started to complain of mid sternal chest pain which lasted that day. He was evaluated in the ER and based on labs and history, admitted for evaluation. His chest pain had resolved by the following day.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, Blood test, Clostridium difficile infection, Clostridium test positive, Computerised tomogram abdomen abnormal
Clinical narrative: June 11- appendicitis occurred. I was hospitalized for 24 hours and received IV antibiotics while in the hospital. Discharged with oral antibiotics. Then had C.Diff 24 hours after hospital discharge and given additional antibiotics.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: June 11- appendicitis occurred. I was hospitalized for 24 hours and received IV antibiotics while in the hospital. Discharged with oral antibiotics. Then had C.Diff 24 hours after hospital discharge and given additional antibiotics.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 17 and given 1st dose of Moderna vaccine.  Moderna is not yet approved for patients under 18 years of age.  Therefore the vaccine was given in error.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Musculoskeletal stiffness, Sleep disorder
Clinical narrative: Beginning the second day following vaccination to current  day, I have the following symptoms:  a stiff neck, severe headache, brain fog, and highly disturbed sleep.,
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Injection site pain, Pain
Clinical narrative: 1) Within 1 minutes left hand went numb, shot in left arm 2) within 5 minutes all hands and feet went numb 3) within 10 minutes felt dizziness  4) within 30 minutes tongue went numb 5) within 18 hours severe pain left arm, shot site 6) within 18 hours fever and flu like body aches  7) within 18 hours poor sleep 8) within 72 hours rash on right shoulder 9) within 72 hours tinnitus  Note, items 2, 8 and 9 remain
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality sleep, Pyrexia, Rash, Tinnitus
Clinical narrative: 1) Within 1 minutes left hand went numb, shot in left arm 2) within 5 minutes all hands and feet went numb 3) within 10 minutes felt dizziness  4) within 30 minutes tongue went numb 5) within 18 hours severe pain left arm, shot site 6) within 18 hours fever and flu like body aches  7) within 18 hours poor sleep 8) within 72 hours rash on right shoulder 9) within 72 hours tinnitus  Note, items 2, 8 and 9 remain
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Skin lesion, Swelling
Clinical narrative: Lesion, redness, bump, extreme itching at injection site
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Blood electrolytes normal, Blood test, Condition aggravated, Diarrhoea
Clinical narrative: 6/16/21 -1 month after 2nd dose of Moderna i started having intestinal issues with chronic diarrhea  and intestinal cramping.  After 3 weeks of no relief (thought it would clear up on its own) and loss of 5lbs, I contacted my doctor and scheduled a visit on June 2, 2021.  After running blood tests and stool tests to rule out other issues It was determined I was having a flare up of diverticulitis as my last colonoscopy in 2020 showed multiple diverticula in my lower colon.  I have never had this issue before.  My doctor prescribed Augmentin, 875 mg.  As of today 7/24/21 my system is getting back to being somewhat normal.   I decided to file this report because I have heard of other women having similar issues and thought I should report.  I did report my issue via the C-19 symptom tracker app and received a call from the CDC about it - but I lost the call back number.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Full blood count normal, Gastrointestinal disorder, Gastrointestinal pain, Metabolic function test
Clinical narrative: 6/16/21 -1 month after 2nd dose of Moderna i started having intestinal issues with chronic diarrhea  and intestinal cramping.  After 3 weeks of no relief (thought it would clear up on its own) and loss of 5lbs, I contacted my doctor and scheduled a visit on June 2, 2021.  After running blood tests and stool tests to rule out other issues It was determined I was having a flare up of diverticulitis as my last colonoscopy in 2020 showed multiple diverticula in my lower colon.  I have never had this issue before.  My doctor prescribed Augmentin, 875 mg.  As of today 7/24/21 my system is getting back to being somewhat normal.   I decided to file this report because I have heard of other women having similar issues and thought I should report.  I did report my issue via the C-19 symptom tracker app and received a call from the CDC about it - but I lost the call back number.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: 6/16/21 -1 month after 2nd dose of Moderna i started having intestinal issues with chronic diarrhea  and intestinal cramping.  After 3 weeks of no relief (thought it would clear up on its own) and loss of 5lbs, I contacted my doctor and scheduled a visit on June 2, 2021.  After running blood tests and stool tests to rule out other issues It was determined I was having a flare up of diverticulitis as my last colonoscopy in 2020 showed multiple diverticula in my lower colon.  I have never had this issue before.  My doctor prescribed Augmentin, 875 mg.  As of today 7/24/21 my system is getting back to being somewhat normal.   I decided to file this report because I have heard of other women having similar issues and thought I should report.  I did report my issue via the C-19 symptom tracker app and received a call from the CDC about it - but I lost the call back number.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Erythema, Food intolerance, Headache, Myalgia
Clinical narrative: pain  and hot the entire back of :L arm, swelling and redness  now Only 2" w  x  4" l   two days later.  Intense stomach pain the day of the injection , lesser the second day. ( could not tolerate solid food, it made the stomach pain worse.)   muscle pain. and headache   I took  1 Aleve and when the headache continued took 1 Maxalt 10 mg - it took the edges off.  did not check for a fever.