chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Hepatitis A immunisation, Product storage error
Clinical narrative: improperly stored vaccine administered; This spontaneous report has been received from a medical assistant referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 31-DEC-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route, frequency and anatomical location were not provided) lot # T013204 with expiration date of 03-DEC-2021  for prophylaxis.  The vaccine was exposed to a temperature below 36 F for 5 hours and 40 minutes. There were no previous temperature excursions and the vaccines were back in range. Data logger was used (product storage error).    combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Error: Diluent Administered Instead of Vaccine; symptoms lasted 0 days
Sex: U
Vaccine: HEPA, UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; Consumer reporting administration of improperly stored VAQTA and VARIVAX; Information has been received from a consumer regarding itself, a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 11-JAN-2021, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot # S037576 with expiration date 10-APR-2021 and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number T020653 with expiration date reported as 12-JUN-2022, but upon internal validation 16-JUN-2022 (dose, route of administration, strength and anatomical location not reported). Both vaccines were administered as prophylaxis.  The varicella virus vaccine live (Oka/Merck) (VARIVAX) and hepatitis a vaccine, inactivated (VAQTA) were stored at a temperature of 14 degrees Fahrenheit (°F) for the time frame of 1 hour and at a temperature of 21.3°F for 1 hour (time frame also reported as 2 hours). There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S037576; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing, Loss of consciousness
Clinical narrative: loss of consciousness; felt flush; felt hot / felt warm; This case was reported by a pharmacist via call center representative and described the occurrence of loss of consciousness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. In November 2020, 1 day after receiving Shingrix, the patient experienced loss of consciousness (serious criteria GSK medically significant), flushing and feeling hot. On an unknown date, the outcome of the loss of consciousness, flushing and feeling hot were unknown.   It was unknown if the reporter considered the loss of consciousness, flushing and feeling hot to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced loss of consciousness, felt warm, felt hot, and felt flush the next day, one day after the first dose of Shingrix (unknown day in November 2020). Consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: synthetic flu from the flu shot; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (grandparent of the patient).  This case involves a male patient of an unknown age who had synthetic flu from the flu shot (influenza), while he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, the patient had synthetic flu from the flu shot (influenza).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Patient complains of fever, chills, body aches, headache and fatigue
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Patient complains of fever, chills, body aches, headache and fatigue
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Seizure like phenomena
Clinical narrative: Patient complains of fever, chills, body aches, headache and fatigue
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I dont get the flu shots anymore. When I did I got sick; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via media.  This case involves an unknown age patient for whom patient did not get the flu shots anymore. when patient did he/she got sick (illness) was reported, while he/she received vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that patient did not get the flu shots anymore. when patient did he/she got sick (illness) (Unknown latency) following the administration of influenza vaccine. So no more shots.  Final diagnosis was patient did not get the flu shots anymore. when patient did he/she got sick.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: in 56 years only had flu like symptoms 3 times, within days of getting a flu shot; Initial information regarding this unsolicited valid non-serious media  case received from a consumer (patient) and transmitted to Sanofi on 08-Dec-2020.  This case involved a patient who experienced flu like symptoms, after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu like symptoms ((influenza like illness) 3 times, within days of getting a flu shot, unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was influenza like illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: The one time I got a flu shot I got to sick; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via media.  This case involves an unknown age patient for whom the one time patient got a flu shot patient got to sick to die not happening again had not the flu In over 15 years (illness) was reported, while he/she received vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that the one time patient got a flu shot patient got to sick to die not happening again had not the flu In over 15 years (illness) (Unknown latency) following the administration of influenza vaccine.  Final diagnosis was the one time patient got a flu shot patient got to sick to die not happening again had not the flu In over 15 years.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Pain
Clinical narrative: Fever of 100.1, chills, body aches (Lower half of body only), headache, extreme fatigue. Missed work. Started at 4 am, about 18 hrs after vaccine given. Lasted 24 hrs.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 100.1, chills, body aches (Lower half of body only), headache, extreme fatigue. Missed work. Started at 4 am, about 18 hrs after vaccine given. Lasted 24 hrs.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got it 25 years ago and I I got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer via media and transmitted to Sanofi on 08-Dec-2020.  This case involved an unknown age patient who reported influenza vaccine got it 25 years ago and got the flu (Influenza).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported.  On unknown date, (latency unknown) patient reported influenza vaccine got it 25 years ago and got the flu (influenza).   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm for a few days; Initial information regarding an unsolicited valid non-serious case received from a consumer via media and transmitted to Sanofi on 13-Dec-2020.  This case involved an unknown age patient who experienced sore arm for a few days (Pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported.  On unknown date, (latency unknown) Got flu shot every year. Patient reported never had a problem except a sore arm for a few days (Pain in extremity), while received vaccine influenza vaccine.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I'm sick one whole month and counting later after my shot.; Initial information received on 12-Dec-2020 regarding an unsolicited valid non-serious case received was received from a consumer (patient) via media.  This case involves an unknown age patient who sick one whole month and counting later after her/his  shot (illness), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that the patient sick one whole month and counting later after her/his shot (illness) (Unknown latency) following the administration of Influenza Vaccine.  Final diagnosis was the patient sick one whole month and counting later after her/his  shot (illness).   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I get sick everytime I used to get it; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via media.  This case involves an unknown age patient who get sick every time, patient used to get it (illness), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that the patient get sick every time, patient used to get it (illness) (Unknown latency) following the administration of Influenza Vaccine.  Final diagnosis was the patient get sick every time, patient used to get it.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea
Clinical narrative: fatigue, chills, slight nausea, dizziness
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick as a dog [Sickness]; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 73-years-old female patient (87.1 kg) who experienced being sick as a dog [sickness] (illness), while she received vaccine INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [REMODULIN].  The patient gets sick every year after getting INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment, and family history were not provided.   At the time of the event, the patient had ongoing pulmonary arterial hypertension.  Concomitant medications included RIOCIGUAT (ADEMPAS); and WARFARIN SODIUM (COUMADIN).  On 10-Nov-2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  From  01-May-2017, the patient started taking REMODULIN concentration 5.0 mg/ml (TREPROSTINIL SODIUM). The current dose of Remodulin was reported 0.048 µg/kg, continuous via intravenous (IV) route (batch number: 935767 and expiry date: 31-Aug-2021) for pulmonary arterial hypertension.  In 2020, the patient developed a non-serious sick as a dog [sickness] (illness) (unknown latency) following the administration of INFLUENZA VACCINE and of TREPROSTINIL SODIUM   The patient as not increasing pump rate for Remodulin until feel better.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of illness was considered as resolving and the patient was feeling a little better.  The reporter assessed the causal relationship between the IV Remodulin and the event of illness as not related.  There will be no information available on the batch number for influenza vaccine for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information received on 18-Dec-2020 regarding an unsolicited valid non-serious case from non-health care professional.  This case involves patient (demographics unknown) who had sore arm (pain in extremity), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (high dose) produced by unknown manufacturer and  also had 13 and 23 shots (name unspecified) [lot number and expiry not reported] via unknown route in an unknown administration site for prophylactic vaccinations.  On an unknown date, the patient developed a non-serious sore arm (pain in extremity) (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the of reporting, the outcome is unknown for sore arm.  There will be no information on the batch number to be requested for this case.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: A week after (1/6/21) the injection the injection the site became itchy.  The next morning (1/7/21) the right arm developed a red area raised  in the shape of a square. It was itchy, hot , hard and sore. After Motrin the symptoms improved but was still there. Symptoms persisted until 1/10/21.  On 1/11/21 the redness was traveling down her upper arm and was hot.  At the moment it is still red and hot but is not painful.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Skin warm
Clinical narrative: A week after (1/6/21) the injection the injection the site became itchy.  The next morning (1/7/21) the right arm developed a red area raised  in the shape of a square. It was itchy, hot , hard and sore. After Motrin the symptoms improved but was still there. Symptoms persisted until 1/10/21.  On 1/11/21 the redness was traveling down her upper arm and was hot.  At the moment it is still red and hot but is not painful.
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: allergy; Initial information was received on 24-Dec-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.  This case involves a 47 year old male patient who experienced allergy (hypersensitivity), after he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergy (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported for hypersensitivity.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Axillary mass
Clinical narrative: incredible allergic reaction causing plum sized lump in lymph glands in the armpit; Initial information received on 29-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient who experienced incredible allergic reaction causing plum sized lump in lymph glands in the armpit (axillary mass), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE 2020-2021 (lot UT7108KA and expiration date not reported)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious incredible allergic reaction causing plum sized lump in lymph glands in the armpit (axillary mass) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the reports, the outcome was not reported for the event axillary mass.
Age: 45.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired vaccine was administered to a patient with no adverse event; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 45 year old male patient who was administered with expired Haemophilus type B (HIB) vaccine (ACT-HIB). (Expired product administered). Caller said the diluent and powder had different expiration dates and she didn't realize that the diluent expired on 26-Nov-2020. The powder was what she checked and it would expire on 26-Feb-2021 so she by mistake used the diluent to mix the powder and gave this patient a dose. Caller was asking how to proceed if they gave an expired ActHIB yesterday.  At the time of the event, the patient had ongoing lung cancer. Had spleen removed in a month (Splenectomy)  Concomitant medications included Meningococcal Vaccine a/c/y/w conj (dip tox) (Menactra); Men b and Pneumococcal Vaccine conj 7v (crm197) (Prevnar).  On 16-Dec-2020, the patient received a once dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE (single dose vials) at a dose of 0.5 ml via intramuscular route at the right deltoid (lot UJ135ABA and expiry date 26-Nov-2020) (Powder lot  UJ135AB expiry was 26-Feb-2021, Liquid part  lot U6477AA expiry was 26-Nov-2020) for prophylactic vaccination.  It was also a case of actual medication due to expired vaccine used (Latency: same day)  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
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Nausea, Poor quality sleep, Tremor
Clinical narrative: 1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking of hands, chills and present at this time 1/14/21
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Lethargy, Nausea, Oral herpes
Clinical narrative: 1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking of hands, chills and present at this time 1/14/21
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error, Wrong technique in product usage process
Clinical narrative: mixed reconstituted dtap/IPV with normal saline that is used to reconstitute other medications with no AE; Initial information received on 06-Jan-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involved a 1 year old male patient who received a 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported), via unknown route at right thigh, on 05-Jan-2021 (Wrong technique in product usage process).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due mixed reconstituted dtap/ipv with normal saline that is used to reconstitute other medications (Wrong technique in product usage process) on same day.    At the time of reporting, the 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.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Expired Tenvac vaccine administered to patient/no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse (other health professional) via Medical Information (Reference number- 00422567) and transmitted to Sanofi on 08-Jan-2021.  This case involves a 34 year old male patient who received an expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6101AA, expiry date: 23-Oct-2020] via an intramuscular route at an unknown administration site for prophylactic vaccination on 08-Jan-2021 (expired product administered). (latency: on the same day)   Medical history, medical treatments, vaccinations, list of concomitant medication and family history were not provided.  Patient received no other vaccines.   It was a case of actual medication error due to expired vaccine used (Latency-same day).  It was reported that, nurse did not have the site Event Information also wanted to know how to proceed further.    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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Insomnia, Pyrexia
Clinical narrative: Over-sleeping on 1/7/21.  Fell asleep @ 5 pm 1/7/21 and slept until 10 am 1/8/21 Insomnia 1/8, 1/9, 1/10 - average 2-4 hours each night Fever of 100.3 on 1/11 from 12 pm till 5 pm
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 1/13/21 Noon, very itchy injection site pea size knot. Today 1/14/21  knot increased sized to half dollar coin size, very red, hot to touch, itchy and painful.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Systemic: Nausea
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palmar-plantar erythrodysaesthesia syndrome, Pruritus, Rash macular
Clinical narrative: Multiple red, itchy spots on hands and feet
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headaches, Fatigue
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product preparation error
Clinical narrative: Diluent Administered Instead of Vaccine; symptoms lasted 0 days
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache and body aches
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Mastication disorder, Speech disorder, Trismus
Clinical narrative: Extreme lockjaw unable to barely talk or chew
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at injection sight for about 4 days.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Moderna Covid-19 Vaccine  sore arm, severe chills the night after the vaccine administered,
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I received my second dose of the Covid vaccine on 1/12 at 11:00am.  At 2:00pm I noticed one large hive on my right cheek.  I did not have any other symptoms or any other hives that I noted on my body.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Hot flush, Neck pain
Clinical narrative: 1 minute after first dose of moderna covid vaccine patient had lightheadedness, neck and jaw pain, hot flash, elevated blood pressure and HR, and near syncope; required transport to ER. Resolved with Benadryl and Zofran and iv fluids.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Presyncope
Clinical narrative: 1 minute after first dose of moderna covid vaccine patient had lightheadedness, neck and jaw pain, hot flash, elevated blood pressure and HR, and near syncope; required transport to ER. Resolved with Benadryl and Zofran and iv fluids.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Low grade fever, whole body aches, severe fatigue that lasted at least 48 hrs
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus rhythm, Tachycardia
Clinical narrative: 33 Y/O FEMALE PATIENT WHO REFERS TACHYCARDIA 30 MINUTES AFTER COVID VACCINE, B/P 141/92,HR 87BPM SAT 100%, RESP 21 BPM, PATIENT IS PLACE ON CARDIAC MONITORING  PER 30 MINUTES, LEAD II HR 81, SINUS RHYTUM. PATIENT WAS DISCHARGE HOME, FEELING WELL NO TACHICARDIA, HEADACHE , NAUSEA OR VOMITING.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash, Rash macular
Clinical narrative: 7 days after vaccine, R arm around injection site became acutely itchy and red, blotchy.  over next 4 hrs, itchy rash spread to R shoulder, chest, neck and R cheek.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Paraesthesia
Clinical narrative: Forehead tingling neck tingling swollen lymph node same arm as the injection Injection site was swollen, red and warm to touch
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Injection site erythema, Injection site indentation, Injection site swelling, Pain in extremity
Clinical narrative: Arm soreness noted on Jan. 5. On Jan. 11 I was sneezing a lot with a runny nose. This last for 24 hrs. On the 12th I noticed a raised area in the injection site. I took an Advil .  On the 13th my arm started getting hard near the injection site with some redness. On that day I took a Benadryl once and Advil BID. Today the arm is very hard, red and is warm to the touch. My temp is 100.2. I took 80 mg ASA and a hour later took an Advil.  I reported all my Sx w/ Moderna. They recommended that I call my PMD for Tx. I contacted my PMD and the health department for treatment and they referred me to CDC. No treatment was suggested or given
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Skin warm, Sneezing
Clinical narrative: Arm soreness noted on Jan. 5. On Jan. 11 I was sneezing a lot with a runny nose. This last for 24 hrs. On the 12th I noticed a raised area in the injection site. I took an Advil .  On the 13th my arm started getting hard near the injection site with some redness. On that day I took a Benadryl once and Advil BID. Today the arm is very hard, red and is warm to the touch. My temp is 100.2. I took 80 mg ASA and a hour later took an Advil.  I reported all my Sx w/ Moderna. They recommended that I call my PMD for Tx. I contacted my PMD and the health department for treatment and they referred me to CDC. No treatment was suggested or given
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Cold sweat, Dizziness, Face injury, Fall, Nausea
Clinical narrative: Per the employee's incident report, "5 hours after receiving the covid19 vaccine i became very nauseous, light headed, and clammy while walking back from the bathroom.  This caused me to faint.  I hit the floor with my chin and had to get sutures"
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Suture insertion, Syncope
Clinical narrative: Per the employee's incident report, "5 hours after receiving the covid19 vaccine i became very nauseous, light headed, and clammy while walking back from the bathroom.  This caused me to faint.  I hit the floor with my chin and had to get sutures"
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Computerised tomogram head normal, Ear pain, Facial paralysis, Hypoaesthesia oral
Clinical narrative: Patient woke with right sided facial droop, right-sided mouth numbness and whole tongue numbness, and two days of right ear pain. Also, erythematous rash on left arm lasting 5-6 days. CT head unremarkable. MRI brain underway.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Rash, Rash erythematous, Troponin normal, White blood cell count increased
Clinical narrative: Patient woke with right sided facial droop, right-sided mouth numbness and whole tongue numbness, and two days of right ear pain. Also, erythematous rash on left arm lasting 5-6 days. CT head unremarkable. MRI brain underway.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Fever, sore throat, chills, congestion, cough, nausea, muscle aches, tachycardia. Treatment: Tylenol with no improvement Outcome: referred for COVID testing
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Tachycardia
Clinical narrative: Fever, sore throat, chills, congestion, cough, nausea, muscle aches, tachycardia. Treatment: Tylenol with no improvement Outcome: referred for COVID testing
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Spontaneous haemorrhage
Clinical narrative: Spontaneous bloody nose day after vaccine. Not severe in nature but have never experienced a spontaneous bloody nose. Resolved fairly quickly.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Headache, Impaired work ability, Pain
Clinical narrative: We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Feeling abnormal, Pyrexia, Somnolence
Clinical narrative: Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: patient experienced fogginess, drowsiness and confusion. was sent to the ER-Severe; symptoms lasted 0 days
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pyrexia
Clinical narrative: it started off with a light fever / then turned into a red mark on my arm! is now larger then the original day
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Oropharyngeal pain
Clinical narrative: Soreness at the injection site and sore throat
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Condition aggravated, Dyspnoea, Impaired work ability
Clinical narrative: EE reports, started to be nauseous overnight, 1/12 into 1/13.   1/13 10 am, chest heaviness, SOB, anxiety, unable to function at work  1/13/2021, to Urgent Care, prescribed zofran for nausea.  Was asked to contact her PCP regarding her HR 130,  EE was on buprion and abruptly stopped taking it for 2 weeks without PCP recommendation, "I thought I didn't need it anymore".  EE reported to OHN on 1/13, she restarted the med and took her first dose on 1/12 and her second one on 1/13.   Covid results negative
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Nausea, SARS-CoV-2 test negative
Clinical narrative: EE reports, started to be nauseous overnight, 1/12 into 1/13.   1/13 10 am, chest heaviness, SOB, anxiety, unable to function at work  1/13/2021, to Urgent Care, prescribed zofran for nausea.  Was asked to contact her PCP regarding her HR 130,  EE was on buprion and abruptly stopped taking it for 2 weeks without PCP recommendation, "I thought I didn't need it anymore".  EE reported to OHN on 1/13, she restarted the med and took her first dose on 1/12 and her second one on 1/13.   Covid results negative
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: She noted 6-8 hours of arthralgias that resolved on their own.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Maternal exposure during breast feeding, Pain, Pain in extremity
Clinical narrative: Sore arm day 2-3 post does. Day 5 post dose, severe Axillary lymphatic pain on injection arm. Still persisting and radiating into arm day 8. Also, breastfeeding and day 8 (post vaccine) experiencing possible  clogged duct on injection side as well (related?).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Blood glucose, Diplopia, Echocardiogram
Clinical narrative: Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision.  I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand.   I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Feeling abnormal, Full blood count, Glycosylated haemoglobin, Hypoaesthesia
Clinical narrative: Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision.  I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand.   I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Lipids, Loss of personal independence in daily activities, Magnetic resonance imaging brain, Metabolic function test
Clinical narrative: Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision.  I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand.   I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Moaning, Muscular weakness, Musculoskeletal disorder, Nausea, Paraesthesia
Clinical narrative: Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision.  I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand.   I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Urine analysis, Vertigo
Clinical narrative: Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision.  I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand.   I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Rash macular
Clinical narrative: she did not disclose any allergies prior to injection. about 10 minutes after the injection, patient c/o dizziness lightheaded feeling flush, she stood up, fanned herself with paperwork, then layed down flat on strecther, noted red blotches on her upper chest, and diaphoretic, removed her facemask. RNs decided to take her into the ER. wheeled her there in wheelchair.  on the way, patient states she may have had a reaction to penicillin in the past. ER  nurses and doctor assessed pt,  according to chart she had several episodes of lightheaded/flushed feelings. given crackers and juice because she had not eaten breakfast. Benadryl po 50mg given. d/c back to work as occupational therapist at hospital outpatient clinic.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: body ache, sore/tender around injection site, nausea
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Myalgia
Clinical narrative: Injection site pain, headache, muscle pain, feeling unwell, tiredness