chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure increased, Blood pressure measurement, Blood test
Clinical narrative: Second Dose: blood pressure went to high; Second Dose: started to black out, if his partner had not been there for him he might be dead right now; Second Dose: blood pressure dropped to 89/56; Second Dose: too weak to walk very far; Second Dose: diarrhea; Second Dose: Nausea; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 09:00 at single dose for COVID-19 immunisation at the age of 66-year-old. Lot number was EN6198. Medical history included ongoing hypertension (10-15 years), ongoing degenerative arthritis since 2010, ongoing Rheumatoid arthritis since 2015, pain, prostate infection (treated with antibiotic; stopped taking the antibiotic and all of his medications), pneumonia in Sep2020 (unrelated to the Covid 19 virus, hospitalization). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Feb2021 at single dose in left arm for COVID-19 immunisation at the age of 66-year-old and he experienced nausea, slight diarrhea, tiredness; lot number was EM9810. Concomitant medications included adalimumab (HUMIRA), methotrexate, hydrocodone. On 18Mar2021, the patient experienced nausea and diarrhea. The patient received ondansetron 4mg tablets, take 1 by mouth every 4 hours as needed for nausea. On 20Mar2021, the patient experienced black out, if his partner had not been there for him he might be dead right at the time of report, it was a bad, bad experience (life-threatening), blood pressure dropped to 89/56 and too weak to walk very far. The patient drank lots of fluids and they were able to get his blood pressure back up, the doctor almost sent him to the hospital to get fluids. Then his blood pressure went to high and he had to get it down. The patient had gone to pick up some groceries and he started to black out. He had to ride in the motorized cart around since he was too weak to walk very far. The patient has had to ride the motorized cart before because he has degenerative arthritis and rheumatoid arthritis. The patient got into his van to leave and he could not drive home. It was only 7 miles but he felt like he would have blacked out and it would have been dangerous; he called his partner and he came to get him. On 21Mar2021, the patient experienced blood pressure went to high. On unknown date, blood pressure resulted high, cystoscopy (urine came back positive for infection), Covid 19 virus test (negative). On 20Mar2021, blood pressure dropped to 89/56. On 22Mar2021, blood work was performed (unknown results). Doctor recommended that he should stop taking his arthritis medications and pain medication. The doctor told him those medications might interfere in getting the Covid 19 vaccine; the patient took immune depressors. The patient did not recover from weakness and nausea, the patient recovered from diarrhea; the outcome of other events was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cystoscopy, Diarrhoea, Loss of consciousness, Nausea, SARS-CoV-2 test
Clinical narrative: Second Dose: blood pressure went to high; Second Dose: started to black out, if his partner had not been there for him he might be dead right now; Second Dose: blood pressure dropped to 89/56; Second Dose: too weak to walk very far; Second Dose: diarrhea; Second Dose: Nausea; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 09:00 at single dose for COVID-19 immunisation at the age of 66-year-old. Lot number was EN6198. Medical history included ongoing hypertension (10-15 years), ongoing degenerative arthritis since 2010, ongoing Rheumatoid arthritis since 2015, pain, prostate infection (treated with antibiotic; stopped taking the antibiotic and all of his medications), pneumonia in Sep2020 (unrelated to the Covid 19 virus, hospitalization). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Feb2021 at single dose in left arm for COVID-19 immunisation at the age of 66-year-old and he experienced nausea, slight diarrhea, tiredness; lot number was EM9810. Concomitant medications included adalimumab (HUMIRA), methotrexate, hydrocodone. On 18Mar2021, the patient experienced nausea and diarrhea. The patient received ondansetron 4mg tablets, take 1 by mouth every 4 hours as needed for nausea. On 20Mar2021, the patient experienced black out, if his partner had not been there for him he might be dead right at the time of report, it was a bad, bad experience (life-threatening), blood pressure dropped to 89/56 and too weak to walk very far. The patient drank lots of fluids and they were able to get his blood pressure back up, the doctor almost sent him to the hospital to get fluids. Then his blood pressure went to high and he had to get it down. The patient had gone to pick up some groceries and he started to black out. He had to ride in the motorized cart around since he was too weak to walk very far. The patient has had to ride the motorized cart before because he has degenerative arthritis and rheumatoid arthritis. The patient got into his van to leave and he could not drive home. It was only 7 miles but he felt like he would have blacked out and it would have been dangerous; he called his partner and he came to get him. On 21Mar2021, the patient experienced blood pressure went to high. On unknown date, blood pressure resulted high, cystoscopy (urine came back positive for infection), Covid 19 virus test (negative). On 20Mar2021, blood pressure dropped to 89/56. On 22Mar2021, blood work was performed (unknown results). Doctor recommended that he should stop taking his arthritis medications and pain medication. The doctor told him those medications might interfere in getting the Covid 19 vaccine; the patient took immune depressors. The patient did not recover from weakness and nausea, the patient recovered from diarrhea; the outcome of other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Had his first vaccination of the Pfizer and 8 days later he passed away; This is a spontaneous report from a contactable consumer.  A male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was reported that the patient had his first vaccination on 20Mar2021 and 8 days later (on 28Mar2021) the patient passed away. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Had his first vaccination of the Pfizer and 8 days later he passed away
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: Brain bleed; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender (physician) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that a perfectly healthy physician who died after receiving the vaccine actually dying from a brain bleed. The outcome of the event was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Brain bleed
Sex: F
Vaccine: FLUX
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: patient got pregnant after vaccination/no AE; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves a female patient of unknown age who got pregnant after she received INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination [maternal exposure before pregnancy].  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine exposure before pregnancy (latency was on same day).  Relevant prenatal testing after exposure was not reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.   There will be no information available on batch number for this case.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: allergy; Initial information was received on 22-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210324000530).  This case involves a female patient who experienced allergy (hypersensitivity), while she received TETANUS TOXOID.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination..  On an unknown date, the patient developed a non-serious allergy (hypersensitivity) unknown latency following the administration of TETANUS TOXOID.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was given one month and one week earlier that it should have been given (with no reported adverse event); Initial information regarding an unsolicited valid non-serious case was received from a other health care professional (Reference number- 00519297) and transmitted to Sanofi on 15-Mar-2021.  This case involves a 17 years old female patient who received second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] one month and one week earlier (Inappropriate schedule of vaccine administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 27-Jul-2015 the patient received first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and on 17-Jun-2019, she received second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   It was a case of an actual medication error due to Inappropriate schedule of vaccine administered.  The caller stated that the patient's second dose was given one month and one week earlier that it should have been given. She wants to know if they can give her one today? The caller would like to know if she can safely administer the next Menactra dose 1 month and 1 week early from the recommended time frame. At this time, the patient is currently in the HCP office to receive her next dose of Menactra.  At the time of reporting, patient had no adverse event.  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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Joint swelling, Malaise, Pain, Pyrexia, Vertigo
Clinical narrative: achiness; joints became swollen, especially her fingers and ankles and feet; general malaise; fever (101F); vertigo; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00523625).  This case involves female patient (age not reported) who experienced fever (101 Fahrenheit) (pyrexia), achiness (pain), general malaise (malaise), vertigo and joints became swollen, especially her fingers and ankles and feet (joint swelling), while she received vaccines INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date (during the 2012-2013 flu season), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (during the 2012-2013 flu season), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient suffered severe adverse reaction of fever (101 Fahrenheit) (pyrexia), achiness (pain), general malaise (malaise), vertigo and joints became swollen, especially her fingers and ankles and feet (joint swelling) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Patient received Adacel and  FLUZONE vaccine on the same day.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: DTAP, FLUX, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: the Ipol that was used for the dose had been exposed to a temperature excursion prior to the administration to this patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00525796) and transmitted to Sanofi on 18-Mar-2021.  This case involves a 10 month old (also reported as: 11 month old) male patient who received IPV (VERO) [IPOL] [lot: RID973M and expiry date: 17-Jul-2021] via an intramuscular route at the right deltoid on 01-Feb-2021 at 12:03 for prophylactic vaccination which had been exposed to a temperature excursion prior to the administration to patient (product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was a case of actual medication error due to incorrect storage of product. It was reported that, after the vaccination on 01-Feb-2021, in Mar-2021, a data log report was performed and the data log showed that the IPOL that was used for the dose had been exposed to a temperature excursion prior to the administration to this patient. As a result of the excursion, that the IPOL was not suitable for use.   First time product used and still using product was reported as no at the time of reporting.   At the time of report, no adverse event was reported.  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: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Expired product administered, Medication error
Clinical narrative: given an expired IPOL with no adverse event; Initial information received on 19-Mar-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 years old male patient who was given an expired 0.5 ml dose of IPV (VERO) [IPOL] (lot R1B251M and expiration date 13-Mar-2021) via intramuscular route in the right thigh for prophylactic vaccination on 10-Mar-2021 (expired product administered) and this was noticed when reporter was entering the information into the computer.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and HEPATITIS A VACCINE (HEPATITIS A).  It was a case of actual medication error due to expired vaccine used (same day latency).  It was not reported whether the patient had any adverse event.  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.  There will be no information on the batch number for this case.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Medication error, Underdose
Clinical narrative: A patient received Adacel 0.1 mL intradermally in his right arm today by mistak, no AE; A patient received Adacel 0.1 mL intradermally in his right arm today by mistake, no AE; Initial information received on 22-Mar-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 47 years old male patient who received 0.1 ml of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number :C5787AA expiration date: 01-Oct-2022), instead of 0.5 ml via intradermal route in the right arm for prophylactic vaccination by mistake on 22-Mar-2021 (incorrect route of product administration, underdose).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TUBERCULIN PPD (TUBERSOL) via intradermally.  It was a case of actual medication error due to vaccine underdose and inappropriate route of vaccination (same day latency).  The reporter would like to know how to proceed in ensuring that the patient receives the correct dose of Adacel. When can the correct dose of Adacel be administered? How soon is Adacel effective? Separately, the patient was supposed to receive Adacel 0.5 mL IM (intramuscular) because his wife has a baby which was due in 2 to 3 weeks.  It was not reported whether the patient had any adverse event.  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: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction to a trivalent influenza vaccine; This spontaneous case received on 05-Apr-2021 from a physician via Med Communications (reference number: SEQW21-01125) and concerned a female patient of an unspecified age.  The patient's medical history and concomitant medications were not reported.  On 24-Sep-2009, the patient was vaccinated with trivalent influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 96033.  On an unspecified date, an unknown amount of time after receiving trivalent influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to the vaccine.  The outcome of the event was not reported.  The reporter assessed the event as related to trivalent influenza virus vaccine polyvalent.  The event of 'anaphylactic reaction to vaccine' was considered to be medically significant by a Physician within Risk Management Department.  The physician stated that the patient had not been under her care nor received the vaccine from her and therefore, no additional details would be provided.  Company comment: A female patient of an unspecified age was vaccinated with trivalent influenza virus vaccine polyvalent. On an unspecified date, an unknown amount of time after receiving trivalent influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to the vaccine. Causality is unassessable, due to unclear information regarding temporal relationship and diagnostic findings. Brighton Collaboration criteria could not be assessed due to insufficient information.; Reporter's Comments: The physician reported that had a patient who experienced an anaphylactic reaction to a trivalent influenza vaccine.; Sender's Comments: A female patient of an unspecified age was vaccinated with trivalent influenza virus vaccine polyvalent. On an unspecified date, an unknown amount of time after receiving trivalent influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to the vaccine. Causality is unassessable, due to unclear information regarding temporal relationship and diagnostic findings. Brighton Collaboration criteria could not be assessed due to insufficient information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Upon administering Janssen COVID19 vaccine, patient experienced vasovagal syncope approximately 5 seconds after administration.  This occured at approximately 11:15 am on 4/10/21.  After approximately 5 to 10 seconds, patient opened eyes, became alert and was assisted to a sitting position where she was observed for approximately 30 minutes.  Patient left pharmacy and was contacted at 1:10 pm to check up on condition.  Patient said she was feeling fine and was thankful for pharmacy's concern.  Patient instructed to contact pharmacy with any questions or change in status.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Somnolence
Clinical narrative: Patient felt lightheaded,  and his brother laid him on the ground and then he passed out for a few seconds. Pt was responsive after but felt drowsy. Pt was given water felt better.  Per discussion with patient, he has a history of getting faint from seeing needles and getting blood drawn.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Feeling abnormal, Gait disturbance, Inappropriate affect
Clinical narrative: 15 min after the shot: dizziness, swollen face , hard to swallow.   45 min after shot: nausea, very week; can't walk alone, sinus stuffiness, excess laughing, lethargy; unclear head
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Sinus congestion, Swelling face
Clinical narrative: 15 min after the shot: dizziness, swollen face , hard to swallow.   45 min after shot: nausea, very week; can't walk alone, sinus stuffiness, excess laughing, lethargy; unclear head
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: VDay,   7pm: Muscle Aches (minor) VDay+1 ,  4am : Fever (103), Chills, Muscle Aches VDay+1,  8am-8pm : Fever(101), Muscle Aches VDay+2, 6am :  Recovered
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash pruritic
Clinical narrative: Pet dander/grass/pollen allergies have gotten increasingly stronger, though the overall effect is mild. I take daily loratadine and hydroxyzine for these, and today I've had to apply my topical steroid to several areas from my hips to my face to combat the itchy rashes and areas of redness.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Janssen COVID-19 Vaccine EUA. Body ache until the following morning (4/8/2021) around 12pm. Chills started around 7pm on 4/7/2021 and also subsided around 12pm on 4/8/2021. I took one Pamprin, from symptom onset, every 6 hours with the last dose at 5:45am on 4/8/2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Intermittent nosebleeds for the next 4 days.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood potassium decreased, Diarrhoea, Dyspnoea, Lactic acidosis
Clinical narrative: Severe vomiting, diarrhea, stomach pain.  Trouble breathing... shaking like a seizure.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Severe vomiting, diarrhea, stomach pain.  Trouble breathing... shaking like a seizure.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Hyperhidrosis, Impaired driving ability, Inappropriate affect
Clinical narrative: Night of vaccine profuse sweating with no fever Next morning severe confusion trying to go to work through mailboxes were deer slamming on breaks thinking they would run out in front.  Tiredness, EXCESSIVE CRYING FOR NO REASON
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Incorrect route of product administration, Injection site pain, Limb discomfort
Clinical narrative: The shot was administered by a young woman at pharmacy, who I later learned was an intern. She injected the shot less than two fingers down from my shoulder bone, much higher than I have ever had an injection given before.  I immediately felt intense pain, and the intern had trouble pushing the syringe down fully.  She said ?I need help!?, and her male manager ran over, and quickly jabbed the syringe further into my arm, and pressed extremely hard down on the syringe, forcing the remaining contents into my arm. I immediately felt a shooting, searing pain down my entire arm, into my wrist, and  my arm went numb, felt heavy, and tingly by my hand.  The manager pulled the needle out of my arm, and said ?you must have hit bone, the needle is bent?.  I then felt extremely nauseous and woozy, and my vision started going in and out.  I fanned myself and after about five minutes my vision stabilized, and I felt less nauseous.  It is now 9 hours later and I have intense shoulder and neck pain, and limited range of motion of my shoulder.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Nausea, Neck pain, Needle issue, Office visit
Clinical narrative: The shot was administered by a young woman at pharmacy, who I later learned was an intern. She injected the shot less than two fingers down from my shoulder bone, much higher than I have ever had an injection given before.  I immediately felt intense pain, and the intern had trouble pushing the syringe down fully.  She said ?I need help!?, and her male manager ran over, and quickly jabbed the syringe further into my arm, and pressed extremely hard down on the syringe, forcing the remaining contents into my arm. I immediately felt a shooting, searing pain down my entire arm, into my wrist, and  my arm went numb, felt heavy, and tingly by my hand.  The manager pulled the needle out of my arm, and said ?you must have hit bone, the needle is bent?.  I then felt extremely nauseous and woozy, and my vision started going in and out.  I fanned myself and after about five minutes my vision stabilized, and I felt less nauseous.  It is now 9 hours later and I have intense shoulder and neck pain, and limited range of motion of my shoulder.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Visual impairment
Clinical narrative: The shot was administered by a young woman at pharmacy, who I later learned was an intern. She injected the shot less than two fingers down from my shoulder bone, much higher than I have ever had an injection given before.  I immediately felt intense pain, and the intern had trouble pushing the syringe down fully.  She said ?I need help!?, and her male manager ran over, and quickly jabbed the syringe further into my arm, and pressed extremely hard down on the syringe, forcing the remaining contents into my arm. I immediately felt a shooting, searing pain down my entire arm, into my wrist, and  my arm went numb, felt heavy, and tingly by my hand.  The manager pulled the needle out of my arm, and said ?you must have hit bone, the needle is bent?.  I then felt extremely nauseous and woozy, and my vision started going in and out.  I fanned myself and after about five minutes my vision stabilized, and I felt less nauseous.  It is now 9 hours later and I have intense shoulder and neck pain, and limited range of motion of my shoulder.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram head
Clinical narrative: When I smile, only the right side of my face reacts. The left side of my face does not react at all. I thought I had a stroke, so I went to the emergency room after two days of being unable to move the left side of my face. They diagnosed it as Bell's palsy and prescribed prednisone (deltasone), 10 Mg tablets for 9 days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Iritis, Malaise
Clinical narrative: I had a very, very severe headache and was nauseous for over 24 hours. I could not sleep even though I was tired, would get out of breath easily, and had chills. After 24 hours I just felt run down for the next 24 hours.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sleep disorder
Clinical narrative: I had a very, very severe headache and was nauseous for over 24 hours. I could not sleep even though I was tired, would get out of breath easily, and had chills. After 24 hours I just felt run down for the next 24 hours.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vertigo positional
Clinical narrative: Five days after the first injection, I experienced debilitating vertigo; my primary care clinic diagnosed BPPV (benign paroxysmal positional vertigo); she prescribed Meclizine and Zofran, and home treatment with the Epley maneuver until symptoms resolved. It took eight days for the condition to resolve.  During that time frame, I had two virtual visits with my primary clinic. The doctor could not say for certain this event was related to my first COVID vaccination. However, I have never experienced this condition in my life, and it occurred within the 7 day window for adverse effects.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Extreme headache, nausea, dizziness Vomiting. Unable to keep down water or food for 14+ hours Dr. consulted after 12 hours. Dr. Prescribed Zofran/ Ondansetron ODT 8 mg tablets Took two doses as directed. Then able to drink and eat a little. Nausea and headache continuing - at times mild, at times moderate. Today is April 10, 3021. Symptoms still  continue.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture negative, Blood lactic acid normal, Body temperature increased, Chest X-ray abnormal, Computerised tomogram abnormal
Clinical narrative: 61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills.  Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen.   Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin.   Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Electrocardiogram normal, Fatigue, Fibrin D dimer
Clinical narrative: 61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills.  Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen.   Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin.   Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Lung consolidation, Lung opacity, Pneumonia, Procalcitonin normal
Clinical narrative: 61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills.  Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen.   Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin.   Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Skin ulcer, Troponin, Ultrasound Doppler, Wheezing
Clinical narrative: 61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills.  Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen.   Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin.   Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count normal
Clinical narrative: 61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills.  Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen.   Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin.   Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills, Headache, and Local Soarness
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Headache, Lymph node pain, Nausea, Pain
Clinical narrative: I woke up on  day 4 after shot and felt pain in my breast and lymph nodes. Same side as my cancer. Very disturbing. I had a horrible reaction, high fever 2 days. Splitting headache. Nausea. Body aches.  I was not aware that lymph nodes could be a reaction and it scared me. Thought my cancer might have come back.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I woke up on  day 4 after shot and felt pain in my breast and lymph nodes. Same side as my cancer. Very disturbing. I had a horrible reaction, high fever 2 days. Splitting headache. Nausea. Body aches.  I was not aware that lymph nodes could be a reaction and it scared me. Thought my cancer might have come back.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness around and slight itching experienced at injection site. Redness approximately 2 inches high by 1.5 inches wide.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Fatigue, Headache
Clinical narrative: A few hours after receiving the "Janssen COVID-19 Vaccine EUA" I started to experience the following side-effects:  headache, fever, muscle aches, tired and weakness.  I also felt a little dizzie.  I monitored my temperature thoughout the night; I recorded  at 7:54pm 99.7; 9:23pm 99.2; 10:45pm 99.8; and at 6:00 am on 4/9 my temperature was back to normal at 97.5. The muscle ache were gone and the headache was mild.  I do still  feel a little dizzie and weak.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: A few hours after receiving the "Janssen COVID-19 Vaccine EUA" I started to experience the following side-effects:  headache, fever, muscle aches, tired and weakness.  I also felt a little dizzie.  I monitored my temperature thoughout the night; I recorded  at 7:54pm 99.7; 9:23pm 99.2; 10:45pm 99.8; and at 6:00 am on 4/9 my temperature was back to normal at 97.5. The muscle ache were gone and the headache was mild.  I do still  feel a little dizzie and weak.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: hive near injection site with itchiness. zyrtec 10 mg PO at 1428, monitored and discharged home by self. Vital signs stable
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever, soreness, chills
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Pyrexia
Clinical narrative: 102.1 fever, strong shoulder pain which has eased somewhat. fever is down to 100.0
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea and arm pain at first. Then throughout the day could not keep down food or water without vomiting.  Last vomit was around 5pm. The next morning, was able to keep down fluids and food. Arm still partially painful.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Pat stated that she had an allergic reaction to the vaccine. She stated she felt itchy.  She had blotches of rash.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Rash
Clinical narrative: Rash, headache, dizziness, fatigue, muscle aches
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: shortness of breath, dizziness and chest pain 7 minutes after injection
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: shortness of breath, dizziness and chest pain 7 minutes after injection
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: C/O chest pain, SOB, dizziness @ 335PM 3:35 VS T 97.4 PR 73 BP 106/74 O2 Sat 95% 3:40 VS T 97.8 PR 68 BP 145/83 O2 Sat 96% and with chest pain/SOB. PT SENT TO ED VIA 911
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: C/O chest pain, SOB, dizziness @ 335PM 3:35 VS T 97.4 PR 73 BP 106/74 O2 Sat 95% 3:40 VS T 97.8 PR 68 BP 145/83 O2 Sat 96% and with chest pain/SOB. PT SENT TO ED VIA 911
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Pallor, Syncope
Clinical narrative: Patient had trouble breathing (and is Asthmatic), and turned white and almost fainted, their brother went to the care to get their inhaler, and we provided orange juice and cold water for the patient.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus developed about 2 weeks after first vaccine shot. Has been 3 days and not subsided. Ringing in both ears.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Lethargy, Nausea, Palpitations
Clinical narrative: Heart palpitations started about 3 hours after vaccination.  Lethargy, headache, nausea and severe abdominal pain started about 24 hours after vaccination.  Symptoms subsided approximately 60 hours after vaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Anticonvulsant drug level therapeutic, Blood copper normal, CSF cell count normal, CSF glucose normal, CSF oligoclonal band absent
Clinical narrative: 2 noticable issues-  The first started 12 hours after the vaccination - (Saturday, March 6) Fever, chills, aches, headaches, nausea.  Went away after 24 hours. The second began with profound feelings of mania 2 days later (Monday, March 8). This subsided in 24 hours. 4 days later- (Wednesday March 10) I began having difficulty standing upright.  This steadily became worse over the next several days until one week after the vaccination, where I was hugging walls and crawling on the floor to move from place to place.   This continued until Monday, March 15, when I was hospitalized.  Everything cleared up after 3 days in the hospital.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: CSF protein normal, CSF white blood cell differential, Chills, Differential white blood cell count normal, Dysstasia
Clinical narrative: 2 noticable issues-  The first started 12 hours after the vaccination - (Saturday, March 6) Fever, chills, aches, headaches, nausea.  Went away after 24 hours. The second began with profound feelings of mania 2 days later (Monday, March 8). This subsided in 24 hours. 4 days later- (Wednesday March 10) I began having difficulty standing upright.  This steadily became worse over the next several days until one week after the vaccination, where I was hugging walls and crawling on the floor to move from place to place.   This continued until Monday, March 15, when I was hospitalized.  Everything cleared up after 3 days in the hospital.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Electrophoresis protein normal, Full blood count normal, Gait disturbance, Headache, International normalised ratio normal
Clinical narrative: 2 noticable issues-  The first started 12 hours after the vaccination - (Saturday, March 6) Fever, chills, aches, headaches, nausea.  Went away after 24 hours. The second began with profound feelings of mania 2 days later (Monday, March 8). This subsided in 24 hours. 4 days later- (Wednesday March 10) I began having difficulty standing upright.  This steadily became worse over the next several days until one week after the vaccination, where I was hugging walls and crawling on the floor to move from place to place.   This continued until Monday, March 15, when I was hospitalized.  Everything cleared up after 3 days in the hospital.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Mania, Metabolic function test normal, Nausea, Pain, Prothrombin time normal
Clinical narrative: 2 noticable issues-  The first started 12 hours after the vaccination - (Saturday, March 6) Fever, chills, aches, headaches, nausea.  Went away after 24 hours. The second began with profound feelings of mania 2 days later (Monday, March 8). This subsided in 24 hours. 4 days later- (Wednesday March 10) I began having difficulty standing upright.  This steadily became worse over the next several days until one week after the vaccination, where I was hugging walls and crawling on the floor to move from place to place.   This continued until Monday, March 15, when I was hospitalized.  Everything cleared up after 3 days in the hospital.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urine analysis normal, Vitamin B12 normal, Vitamin E
Clinical narrative: 2 noticable issues-  The first started 12 hours after the vaccination - (Saturday, March 6) Fever, chills, aches, headaches, nausea.  Went away after 24 hours. The second began with profound feelings of mania 2 days later (Monday, March 8). This subsided in 24 hours. 4 days later- (Wednesday March 10) I began having difficulty standing upright.  This steadily became worse over the next several days until one week after the vaccination, where I was hugging walls and crawling on the floor to move from place to place.   This continued until Monday, March 15, when I was hospitalized.  Everything cleared up after 3 days in the hospital.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: 8 hrs after vaccine had fever if 104 and pulse of 125. Very weak and dizzy. This continued until the next morning.Took 1300 MG acetaminophen.  Had no effect. Used ice bags, had no effect.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, Pain in extremity, Somnolence
Clinical narrative: Patient was inadvertently given a COVID19 vaccine as the second dose after receiving a COVID19 vaccine.  Patient was given one manufacturer on 3/28/21 at another pharmacy and incorrectly thought he had missed his second dose.  He came to our pharmacy to get the second dose, and it was not realized he had already received different manufacturer just 12 days before.  Patient is not experiencing any unusual adverse effects, just a sore arm and drowsiness as would be expected after theCOVID19 vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Neuralgia
Clinical narrative: Severe joint pain (like arthritis) in all joints. It is not going away after12 days. Also, severe nerve pain in left side of body. This has never happened to me before.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Severe joint pain (like arthritis) in all joints. It is not going away after12 days. Also, severe nerve pain in left side of body. This has never happened to me before.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dry mouth, Gait disturbance, Herpes zoster
Clinical narrative: Immediate dry mouth (under 1 minute). Watery eyes/pupils dilated (under 1 minute). Dizziness, light-headed (within 3 minutes). Hot flashes, severe sudden perspiration head/upper torso (within 10 mins). Severe sudden nausea, light-headed, muscle aches-- 5 hrs later. Fever, muscle/joint aches, sore throat-- 6 hrs later. Took 2 acetaminophen. Sore throat, muscle/joint aches next morning, continued throughout first 36 hrs. These symptoms returned every other day for first week, then a rash presented on Day 7 on chest and upper abdomen. Doctor visit on Day 7 (Mon, 5 April 2021).  Shingles on scalp presented on Day 9 (7 April 2021). Virtual Doctor visit on 8 April. Rx for 7-day course of Valtrex. Referral to Dermatology. Day 12--Crippling body aches on right side. Can hardly walk or move around the house. Severe muscle aches.