chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Sensation of foreign body, Throat clearing, Throat tightness, Tonsillectomy, Vocal cord paralysis
Clinical narrative: Left vocal cord paralysis; hoarseness/raspy voice; dysphagia/has trouble swallowing; Choking sensation; Sore throat/throat pain; This case was reported by a lawyer and described the occurrence of vocal cord paralysis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced vocal cord paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the vocal cord paralysis was unknown.   It was unknown if the reporter considered the vocal cord paralysis to be related to Shingrix.  The initial information received on 10 December 2020; via medical records as per records the male patient had history of hypertension. As per pharmacy records on 26 July 2019, he prescribed with SHINGRIX 0.5 ml , intramuscular and on 27 September 2019, SHINGRIX 0.5 ml , intramuscular. As per records on 06 September 2019, evaluation in regards to hoarseness. Onset was about 4 weeks ago. Afterward, he started to notice that his voice was raspy. He stated that throat feels closed off and something caught in his throat causing him to clear throat often. He reports dysphagia that was worse when he swallowed. He has a "choking" sensation". Throat is "sore". Pain scale 6/10. On 17 December 2019, he had was quite weak and he had trouble swallowing. His neurologist believed his VC paralysis was due to the Shingles vaccine. He also mentioned his doctor thought his gut paralyzed. This may be consistent with paralysis of the vagus nerve. On an unknown date, he was hospitalized for tonsillectomy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Chest pain, Herpes zoster, Impetigo
Clinical narrative: Shingles outbreak; rash across chest; blisters on chest; Impetigo; Nerve pain; postherpetic neuralgia; Lumbago with sciatica; Pityrosporum folliculitis; This case was reported by a lawyer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  The initial information was received on 10 December 2020 via medical record (case is now medically confirmed). The patient ingested 50 MCG shingrix injection from 02 October 2019. On 06 October 2019, patient had full blown shingles outbreak over the left chest area and near left scapular region. On 09 October 2019, patient had shingles was Zoster without complications, after taken vaccine 4 days later had pain and rash across chest area still with blisters. The patient had Impetigo. 07 November 2019 patient had Nerve pain from shingles, postherpetic neuralgia, Intercostal pain, Lumbago with sciatica, left side, Pityrosporum folliculitis.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Neuralgia, Rash, Sciatica, Tinea versicolour
Clinical narrative: Shingles outbreak; rash across chest; blisters on chest; Impetigo; Nerve pain; postherpetic neuralgia; Lumbago with sciatica; Pityrosporum folliculitis; This case was reported by a lawyer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  The initial information was received on 10 December 2020 via medical record (case is now medically confirmed). The patient ingested 50 MCG shingrix injection from 02 October 2019. On 06 October 2019, patient had full blown shingles outbreak over the left chest area and near left scapular region. On 09 October 2019, patient had shingles was Zoster without complications, after taken vaccine 4 days later had pain and rash across chest area still with blisters. The patient had Impetigo. 07 November 2019 patient had Nerve pain from shingles, postherpetic neuralgia, Intercostal pain, Lumbago with sciatica, left side, Pityrosporum folliculitis.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Injection site rash
Clinical narrative: soreness of the injected arm; 3x3 inches rash at the injection stie; sweating; fever; weekness; nausea; chills; neckache; headache; rash grew to involve the anterior part of her left arm from the shoulder to her elbow; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 25th November 2020 08:00, the patient received the 1st dose of Shingrix. On 25th November 2020 22:00, 14 hrs after receiving Shingrix, the patient experienced pain in arm, injection site rash, sweating, fever, weakness, nausea, chills, neck pain, headache and rash. On an unknown date, the outcome of the pain in arm, injection site rash, sweating, fever, weakness, nausea, chills, neck pain, headache and rash were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site rash, sweating, fever, weakness, nausea, chills, neck pain, headache and rash to be related to Shingrix.  Additional details were provided as follows:   The patient received 1st dose of shingrix and experienced soreness of the injected arm, headache, neckache, chills, nausea, weakness, fever, sweating, 3x3 inches rash at the injection site and within two days the rash grew to involve the anterior part of her left arm from the shoulder to her elbow. The reporter mentioned that all events were resolved. This case has been linked with US2020236523, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236523:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: soreness of the injected arm; 3x3 inches rash at the injection stie; sweating; fever; weekness; nausea; chills; neckache; headache; rash grew to involve the anterior part of her left arm from the shoulder to her elbow; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 25th November 2020 08:00, the patient received the 1st dose of Shingrix. On 25th November 2020 22:00, 14 hrs after receiving Shingrix, the patient experienced pain in arm, injection site rash, sweating, fever, weakness, nausea, chills, neck pain, headache and rash. On an unknown date, the outcome of the pain in arm, injection site rash, sweating, fever, weakness, nausea, chills, neck pain, headache and rash were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site rash, sweating, fever, weakness, nausea, chills, neck pain, headache and rash to be related to Shingrix.  Additional details were provided as follows:   The patient received 1st dose of shingrix and experienced soreness of the injected arm, headache, neckache, chills, nausea, weakness, fever, sweating, 3x3 inches rash at the injection site and within two days the rash grew to involve the anterior part of her left arm from the shoulder to her elbow. The reporter mentioned that all events were resolved. This case has been linked with US2020236523, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236523:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Soreness at the injection site; Injection site with welts; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain and injection site wheal. On an unknown date, the outcome of the injection site pain and injection site wheal were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site wheal to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter was nurse at the pediatric office. The reporter stated that multiple pediatric patients had soreness at the injection site with welts which lasted for more than 24 hours.  No additional information was provided. Fax and email details were not available. The reporter consented to follow-up.
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Injection site scab
Clinical narrative: Crusty rash at the injection site; Crusty rash at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 7-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2017-2018 season) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2017-2018 season (intramuscular). On an unknown date, unknown after receiving FluLaval Quadrivalent 2017-2018 season, the patient experienced injection site rash and injection site scab. On an unknown date, the outcome of the injection site rash and injection site scab were recovered/resolved.   It was unknown if the reporter considered the injection site rash and injection site scab to be related to FluLaval Quadrivalent 2017-2018 season.  Additional details were provided as follows: The age at vaccination was not reported. On an unknown date in 2017, the patient received the vaccine at the left deltoid.  The patient developed a crusty rash at the injection site lasting for 2 weeks. The reporter consented to follow-up.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Arm soreness; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received 1st dose of Shingrix in unknown deltoid on 8th or 9th October 2020. The patient also received an unspecified flu shot that same day.  The patient stated that the Shingrix shot was given in one arm and the flu shot was given in the other arm.  The patient stated that the patient did had arm soreness in the arm where Shingrix was injected that night while sleeping she couldn't lay on that side.  The arm soreness did not last more than 24 hours, as she recalls. Also that night after receiving the Shingrix and Flu shot she did have chills but the chills were not so bad that they prevented her from being able to sleep. The chills resolved.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247388:Same reporter. 2nd dose
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Malaise, Syncope
Clinical narrative: faint; passed out; feeling crappy; This case was reported by a consumer via call center representative and described the occurrence of faint in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd September 2020, 1 days after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant) and feeling unwell. On an unknown date, the outcome of the faint, passed out and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the faint, passed out and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patient received the 1st dose of Shingrix vaccine. The patient woke-up the next morning feeling crappy and faint. The reporter also stated that she passed out on 2nd September 2020.  The reporter stated pharmacy would not provide her with second shot due to her passing out. The reporter had no physician, but gave permission to follow-up with pharmacy.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247386:same reporter
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received 2 injections of MENACTRA, one at 11 years and second at 18 years old with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other healthcare professional via phone at a call center as a Global Medication Inquiry on 25-Nov-2020.  This case involved a 18-year old male patient who received two injections of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (MENACTRA), one at age of 11 years and second at age of 18 years old with no adverse event (inappropriate schedule of product administration).  Past vaccination(s) included MENACTRA at 11 years of age.  Medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2020, the patient received a second dose in series of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 mL once (lot number: U6787AB, expiry date: 11-Aug-2021) via intramuscular route in the left arm for prophylactic vaccination (Inappropriate schedule of product administration) (latency same day).  This is a true medication error case since there was an inappropriate schedule of vaccine administered..  At the time of reporting, the patient did not experience 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: U
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: patient collapsed in the parking lot on the way to car; Initial information received on 17-Dec-2020 regarding an unsolicited valid serious social media case from consumer (patient) via social media .  This case involves a patient with unknown demographic who collapsed in the parking lot on his/her way to the car (syncope), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication 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 an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient collapsed in the parking lot on his/her way to the car (syncope) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant as per Important Medical Event (IME) list. Reporter stated could get a bad reaction, no more shots for him/her.  Details of laboratory data was not reported.    It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient with unknown demographic who presented with syncope after vaccination with  INFLUENZA VACCINE produced by unknown manufacturer. The time to onset was unknown. However, patient's medical condition at the time of vaccination, Concomitant medication and laboratory tests were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: F
Vaccine: DT
Symptoms: Anaphylactic reaction, Eye swelling, Lip swelling, Skin test positive, Sleep disorder
Clinical narrative: anaphylactic reaction tongue, eyes, face swelled with hives over her body; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) via Medical Information (MI) (Reference number- 00397309) and transmitted to Sanofi on 17-Dec-2020.  This case involved Elderly female patient who experienced anaphylactic reaction tongue, eyes, face swelled with hives over her body (anaphylactic reaction), while she received vaccine DIPHTHERIA AND TETANUS TOXOIDS.   The patient's past medical treatment included EPINEPHRINE, 60 years ago from dental work where they used an anesthetic with epinephrine in it.  The patient's medical history, vaccinations, concomitant medications and family history were not provided.  On an unknown date, Patient stated that 6 or 7 year ago (now 80 years old)  got a DIPHTHERIA AND TETANUS TOXOIDS booster dose(produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination had a severe anaphylactic reaction tongue, eyes, face swelled with hives over her body (anaphylactic reaction). It took a week to get back to normal. She got the shot in Joplin. She stated she did report to Sanofi and the number that was on the paper to report.   Patient would like to know what was in that vaccine, because she is concerned about getting the covid vaccination.  Patient stated she was temporarily living with her daughter. Patient stated that she doesn't know which vaccine she had but remembers calling Sanofi at the time of the adverse event because that was phone number they gave to her. She stated that she was in the home babysitting small children when she got the vaccine but when she told her physician about it the physician told her she had already had the booster so didn't need the one that caused her the issues. Mentions 1-2 days after the injection she woke up in the middle of the night with hives, lips and face swelling and received Benadryl then went to the urgent care and they gave her an injection but it took a week for the hives to go away. She has had a scratch test for allergies but had an anaphylactic reaction to that also and they had to stop the test.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for anaphylactic reaction.; Sender's Comments: This case involved Elderly female patient who had reported anaphylactic reaction with tongue, eyes, face swelled with hives over her body (anaphylactic reaction), with DIPHTHERIA AND TETANUS TOXOIDS booster dose (produced by unknown manufacturer). The time to onset is unknown. Further information regarding previous vaccination, tolerance and laboratory tests ruling out alternate etiologies are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: DT
Symptoms: Swelling face, Swollen tongue, Urticaria
Clinical narrative: anaphylactic reaction tongue, eyes, face swelled with hives over her body; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) via Medical Information (MI) (Reference number- 00397309) and transmitted to Sanofi on 17-Dec-2020.  This case involved Elderly female patient who experienced anaphylactic reaction tongue, eyes, face swelled with hives over her body (anaphylactic reaction), while she received vaccine DIPHTHERIA AND TETANUS TOXOIDS.   The patient's past medical treatment included EPINEPHRINE, 60 years ago from dental work where they used an anesthetic with epinephrine in it.  The patient's medical history, vaccinations, concomitant medications and family history were not provided.  On an unknown date, Patient stated that 6 or 7 year ago (now 80 years old)  got a DIPHTHERIA AND TETANUS TOXOIDS booster dose(produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination had a severe anaphylactic reaction tongue, eyes, face swelled with hives over her body (anaphylactic reaction). It took a week to get back to normal. She got the shot in Joplin. She stated she did report to Sanofi and the number that was on the paper to report.   Patient would like to know what was in that vaccine, because she is concerned about getting the covid vaccination.  Patient stated she was temporarily living with her daughter. Patient stated that she doesn't know which vaccine she had but remembers calling Sanofi at the time of the adverse event because that was phone number they gave to her. She stated that she was in the home babysitting small children when she got the vaccine but when she told her physician about it the physician told her she had already had the booster so didn't need the one that caused her the issues. Mentions 1-2 days after the injection she woke up in the middle of the night with hives, lips and face swelling and received Benadryl then went to the urgent care and they gave her an injection but it took a week for the hives to go away. She has had a scratch test for allergies but had an anaphylactic reaction to that also and they had to stop the test.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for anaphylactic reaction.; Sender's Comments: This case involved Elderly female patient who had reported anaphylactic reaction with tongue, eyes, face swelled with hives over her body (anaphylactic reaction), with DIPHTHERIA AND TETANUS TOXOIDS booster dose (produced by unknown manufacturer). The time to onset is unknown. Further information regarding previous vaccination, tolerance and laboratory tests ruling out alternate etiologies are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness postural, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: 15 minutes after vaccines became dizzy when she stood up. B/P elevated 158/85.  Was extremely fatigued and localized site redness, swelling and pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: 15 minutes after vaccines became dizzy when she stood up. B/P elevated 158/85.  Was extremely fatigued and localized site redness, swelling and pain.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Respiratory tract congestion
Clinical narrative: Muscle aches, headache and congestion
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea/Headache
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash from neck to pubic bone started 12/23 at 5am. Called and spoke with patient this am, 12/24 at 11am. rash is subsiding and she feels fine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy nose and chin. Lasted about 5 minutes
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dizziness postural, Headache, Hyperhidrosis
Clinical narrative: At 1800 developed headache, 2000 developed chills, temperature of 99.6 (normal daily T on this thermometer 96.8-97.5), slight nausea, dizziness with standing.  Excederin at 0000, sweating at 0100, T 98.2 at 0400.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: At 1800 developed headache, 2000 developed chills, temperature of 99.6 (normal daily T on this thermometer 96.8-97.5), slight nausea, dizziness with standing.  Excederin at 0000, sweating at 0100, T 98.2 at 0400.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Flushing, Throat irritation
Clinical narrative: "Scratchy" throat, dizzy, shortness of breath, and flushed approx. 10 minutes post vaccination.  Evaluated onsite at vaccine clinic by physician.  Received diphenhydramine 25MG PO.  VS normal and stable.  O2 Sat at 100%.  Monitored and observed for 60 minutes and D/C'd in stable condition.  Contacted by phone in AM of 12/24/2020 and states all sxs resolved yesterday evening.  Will receive 2nd dose of vaccine in hospital Allergy Clinic.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hyperhidrosis, Nasal congestion, Pain in extremity, Saliva altered
Clinical narrative: At around 3 am. I woke due to excessive sweating and coughing. I also experienced a stuffy nose as well as feeling as though my saliva was thick. I drank water in an attempt to aid the coughing and the water also seemed 'thick'.   I sweat throughout the remainder of the night; in addition to severe left arm pain.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: The COVID vaccine was given at 2046. At approx. 2050 patient complained of tingling to her left leg and a headache. Her vitals were obtained at 2050. They are as follows; B/P 146/86, HR 111, Spo2 98 on RA. She denied any SOB, chest pain or discomfort, no difficulty swallowing. She was able to ambulate to the wheelchair without any issues. I called house supervisor at 2049. He came up to asses her and she was transported to the ED by 2 MA's and a nurse. She was transported via wheelchair on the monitor. She did not require supplemental O2
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Had a low fever (99.5) last night.  Minor aches.    This morning I woke up and the lymph nodes under my left arm are swollen
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Body temperature increased, Bradycardia, COVID-19 pneumonia
Clinical narrative: 12-18 0730- received vaccine at work.  I am a registered nurse. 12-19 11am feeling extremely fatigued, chills, mild aches, and temp 100.1 12-19 2pm  temp 101.8 and more severe arthalgia, myalgia, and shivering.... cant get warm 12-19 6pm temp 102.1 and rigors.... shaking head to toe and severe aches/ pains 12-19 11pm temp 104.1  12-20 temp 102.5 12-21  SOB, bradycardia to 41, dizziness, temp 100.5 12-22 SOB, vomiting, cough, temp 99.6 12-23 SOB, cough, diagnosed with Covid pneumonia
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chills, Computerised tomogram abnormal, Cough, Dizziness
Clinical narrative: 12-18 0730- received vaccine at work.  I am a registered nurse. 12-19 11am feeling extremely fatigued, chills, mild aches, and temp 100.1 12-19 2pm  temp 101.8 and more severe arthalgia, myalgia, and shivering.... cant get warm 12-19 6pm temp 102.1 and rigors.... shaking head to toe and severe aches/ pains 12-19 11pm temp 104.1  12-20 temp 102.5 12-21  SOB, bradycardia to 41, dizziness, temp 100.5 12-22 SOB, vomiting, cough, temp 99.6 12-23 SOB, cough, diagnosed with Covid pneumonia
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myalgia, Pain, Tremor
Clinical narrative: 12-18 0730- received vaccine at work.  I am a registered nurse. 12-19 11am feeling extremely fatigued, chills, mild aches, and temp 100.1 12-19 2pm  temp 101.8 and more severe arthalgia, myalgia, and shivering.... cant get warm 12-19 6pm temp 102.1 and rigors.... shaking head to toe and severe aches/ pains 12-19 11pm temp 104.1  12-20 temp 102.5 12-21  SOB, bradycardia to 41, dizziness, temp 100.5 12-22 SOB, vomiting, cough, temp 99.6 12-23 SOB, cough, diagnosed with Covid pneumonia
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 12-18 0730- received vaccine at work.  I am a registered nurse. 12-19 11am feeling extremely fatigued, chills, mild aches, and temp 100.1 12-19 2pm  temp 101.8 and more severe arthalgia, myalgia, and shivering.... cant get warm 12-19 6pm temp 102.1 and rigors.... shaking head to toe and severe aches/ pains 12-19 11pm temp 104.1  12-20 temp 102.5 12-21  SOB, bradycardia to 41, dizziness, temp 100.5 12-22 SOB, vomiting, cough, temp 99.6 12-23 SOB, cough, diagnosed with Covid pneumonia
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Dose given was 1.0 ml instead of 0.5 ml
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: started to experience scratchy throat, lasted about 30 minutes and resolved on its own.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Loss of consciousness, Syncope
Clinical narrative: Developed severe epigastric pain and had a syncopal episode while at lunch. Individual lost consciousness for a few seconds and returned to baseline with in a minute. No further care was needed or given.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache
Clinical narrative: Headache beginning from time of wake-up about 0730. Pain slightly diminished but not relieved with migraine medication 4 hours later.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Headache
Clinical narrative: diarrhea, shortness of breath, chest pain, headache
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling, pain at injection site Shivering Fever Upset stomach Tired and sore Symptoms lasted through the night, still had fever in the morning. Took a Tylenol in the morning, eventually started to feel better. Slept a lot throughout day, fever subsided during the day. Felt back to normal second day after vaccine
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Flushing, Rash macular
Clinical narrative: blotchy rash flanks, not itchy. 'Flushed' head to toe. Dry Mouth
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever starting at 5am on day after vaccination. Highest measured temperature was 102F. Also had associated fatigue and headache. Headache was helped by acetaminophen and ibuprofen. Fever was intermittent and lasted until about 6pm of the same day.  Fatigue and headache also lasted until about 6pm on day after vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Emotional distress, Headache, Hot flush, Hypoaesthesia
Clinical narrative: Headache: 2/10, global/ diffuse, responds to excedrin & getting, worse in the morning.  +R Foot went numb and the resolved. No tingling, weakness, or numbness, dysphagia, slurred speech, seizures, blurry vision.  Thirst: Very thirsty.  ALtered Mentation: Slower in responding, Having to really think before she speaks  Muscle Spasms  +hot flashes  no fever, chills, chest pain, or sob.  hyper-emotional (Sponteneous crying).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lack of spontaneous speech, Mental status changes, Muscle spasms, Slow response to stimuli, Thirst
Clinical narrative: Headache: 2/10, global/ diffuse, responds to excedrin & getting, worse in the morning.  +R Foot went numb and the resolved. No tingling, weakness, or numbness, dysphagia, slurred speech, seizures, blurry vision.  Thirst: Very thirsty.  ALtered Mentation: Slower in responding, Having to really think before she speaks  Muscle Spasms  +hot flashes  no fever, chills, chest pain, or sob.  hyper-emotional (Sponteneous crying).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: Started 12/23/2020: Body Aches, Sore Arm, Fatigue, Cold Chills, Elevated Temp from normal.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pain, SARS-CoV-2 test
Clinical narrative: Received the COVID vaccine on 12/22/2020 - approximately 4 hours later started with body aches, took NSAID and went to bed, woke up with loss of taste and smell and other COVID symptoms
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Achiness in neck
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Clonic convulsion, Condition aggravated, Dizziness, Hyperhidrosis, Memory impairment
Clinical narrative: Patient was in the 15 minute post-observation window and was scheduling his appt for second dose. Patient noted that he has a fear of needles and mentioned that he was feeling light-headed and experiencing tunnel vision..  He subsequently became diaphoretic and syncopal. He spontaneously recovered and was helped back into the chair. Did not fall to ground or hit his head. A SWAT was called. During SWAT evaluation, patient was given cool compress for neck and mentioned that this has happened before with injections. Subsequently had another syncopal episode and witnessed clonic seizure of roughly 25 seconds in duration. Patient again spontaneously recovered and was brought to the ED. the patient was unable to recall the events and has no history of seizure activity. Patient was given crackers and juice in ED and monitored for approximately 3 hours. Patient was discharged to home.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tunnel vision
Clinical narrative: Patient was in the 15 minute post-observation window and was scheduling his appt for second dose. Patient noted that he has a fear of needles and mentioned that he was feeling light-headed and experiencing tunnel vision..  He subsequently became diaphoretic and syncopal. He spontaneously recovered and was helped back into the chair. Did not fall to ground or hit his head. A SWAT was called. During SWAT evaluation, patient was given cool compress for neck and mentioned that this has happened before with injections. Subsequently had another syncopal episode and witnessed clonic seizure of roughly 25 seconds in duration. Patient again spontaneously recovered and was brought to the ED. the patient was unable to recall the events and has no history of seizure activity. Patient was given crackers and juice in ED and monitored for approximately 3 hours. Patient was discharged to home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 1.0 ml given instead of 0.5 ml
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Paraesthesia
Clinical narrative: My arm from 7pm-7am exp pain, tingling and purple in color. On 12/21 went to employee health nurse told to take Ibuprofen went home. As of today still purple and yellow in 3 to 4 inches in bruise. I dint miss any days of work.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: I WOKE UP IN THE MIDDLE OF THE NIGHT WITH PAIN, SWELLING, HARDNESS AND REDNESS ON THE INJECTION SITE OF UPPER LEFT ARM.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore in arm
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity
Clinical narrative: Woke up in the night with c/o headache, malaise and soreness in the arm COVID vaccine administered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Pain, Pain in extremity
Clinical narrative: I had a headache about an hour after the vaccine. Started feeling extremely tired around 8pm. Around bedtime I was really cold, my hands were like ice and I just kept trying to get warm. I woke up feeling fine this morning. The only pain I feel is that my left arm feels sore and aches when I move the muscle around.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: I had a headache about an hour after the vaccine. Started feeling extremely tired around 8pm. Around bedtime I was really cold, my hands were like ice and I just kept trying to get warm. I woke up feeling fine this morning. The only pain I feel is that my left arm feels sore and aches when I move the muscle around.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: 12/22/2020  at 3:00pm Moderna Vaccine administered. 12/23/2020 at 2:00pm  Strong shaking chills. Temperature started at 99.8. 12/23/2020 at 4pm Chills continue. Temp 101.4 Body aches. 12/23/2020 4:30pm Advil 3 tabs taken. 12/23/2020 6pm Temp 102 chills body aches. 12/24/2020  8am Temp 100.4 12/24/20 11:30 am Temp 99.5improving,  body aches but no chills.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: The day after receiving the vaccine, I developed rhinorrhea, ST, and dry cough. It worsened  the next day, so I got a rapid COVID test that was positive. (This was confirmed with a positive PCR  2 days later). Two days after the vaccine (the day of the positive test), I developed fever to 103, chills, body aches, fatigue, headache and worsening cough/congestion. Fever and chills resolved after 24 hrs, but mild congestion and cough has persisted until today.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: The day after receiving the vaccine, I developed rhinorrhea, ST, and dry cough. It worsened  the next day, so I got a rapid COVID test that was positive. (This was confirmed with a positive PCR  2 days later). Two days after the vaccine (the day of the positive test), I developed fever to 103, chills, body aches, fatigue, headache and worsening cough/congestion. Fever and chills resolved after 24 hrs, but mild congestion and cough has persisted until today.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Nausea, Vomiting
Clinical narrative: within minutes after receiving vaccination employee felt lightheadedness,, clammy, nauseated  and vomited x 1.  slowly resolved, went back to work and totally did not resolve so sent employee to ED to be evaluated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Lip blister, Lip swelling
Clinical narrative: Immediately after I received the injection, my upper lip started tingly. My lip started getting bigger, I took Valtrex as a blister came upon my lip. About 6pm , I started getting a mild headache. I woke up this morning and my headache  is getting worse, I have body aches, and fatigue. My arm is sore as well.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia oral
Clinical narrative: Immediately after I received the injection, my upper lip started tingly. My lip started getting bigger, I took Valtrex as a blister came upon my lip. About 6pm , I started getting a mild headache. I woke up this morning and my headache  is getting worse, I have body aches, and fatigue. My arm is sore as well.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 1.0 m. given instead of 0.5 ml
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event reported. Found in paperwork that this person was only 16 years of age and should not have received Moderna Vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Pt received vaccination and immediately afterwards syncoped.  Pt recalls receiving the inoculation and becoming acutely lightheaded before losing consciousness.  No preceding SOB or palpitations noted.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Pt received vaccination and immediately afterwards syncoped.  Pt recalls receiving the inoculation and becoming acutely lightheaded before losing consciousness.  No preceding SOB or palpitations noted.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia
Clinical narrative: line of numbness from injection site down arm
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Urticaria, allergic reaction to COVID-19 vaccine, treatment with famotidine and benadryl, along with prednisone for 5 days.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Palpitations
Clinical narrative: 15 min post injection c/o heart racing, rate 160 on watch Skin flush Confirmed heart rate 160 RRT called , pt never LOC Pt stayed 1 hour for observation, heart rate 106.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Pain in extremity
Clinical narrative: Patient began experiencing hot flashes and chills a few hours after receiving the vaccine. The next day she experienced chills, fatigue, left arm pain (same arm as vaccine administration). Advised to obtain COVID19 testing, and seek immediate medical attention if symptoms worsen or severe symptoms appear.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Visual impairment
Clinical narrative: About 5 minutes after receiving the vaccine, the individual reported feeling light headed and stated that her "vision wasn't matching up." She was assisted to a laying position and symptoms did not resolve. She was given 50 mg of benadryl IM in her right arm. 15 minutes later, her symptoms resolved and she was able to go home.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Limb discomfort, Pharyngeal paraesthesia, Productive cough, Rash
Clinical narrative: flush on legs and arms, transient throat tingles that resolved. Arms heavy
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Rash, Urticaria
Clinical narrative: A rash started under both armpits in the middle of the night. The armpits were swollen and welped . The rash continued to spread across my chest and back and down both arms . Went to doctor and got medrol dosepack and triamcinolone cream.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 1.0 ml given instead of 0.5 m.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Fever, headache, chills, muscle pain all over,  joint pain, general malaise
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, headache, chills, muscle pain all over,  joint pain, general malaise
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: Feels like lump in back of throat, given Epi at clinic without resolution.  No shortness of breath or pain
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Injection site discolouration, Injection site mass, Injection site pain, Pain
Clinical narrative: EXTREME BRUSING ON THE 10/6/20, THEN ON 11/1/20 RECEIVED THIS MESSAGE FROM PATIENT:  I mentioned that I had tendonitis in my right elbow from playing tennis. I am VERY dominant right sided and used my left arm a lot while letting my right elbow heal. My elbow has gotten much better but I now have a significant pain in the center of my left bicep and I have not been able to lift my arm without pain for over two weeks. I do not remember any one significant incident that created the pain. I have been wearing a sling but it hasn't helped a lot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: I THREW UP  4-5 TIMES AND HAD DIARRHEA AROUND 9PM, AND SLIGHT DIZZINESS PRIOR TO THAT
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 1 ml given instead of 0.5 ml
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye swelling, Injection site erythema, Injection site swelling, Ocular hyperaemia
Clinical narrative: About 24 hours after the vaccine, arm became red and swollen at the injection site. Eyes became red and swollen. Experienced coughing if laying flat, had to sleep upright. Symptoms resolved around 12 hours later.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: About 24 hours after the vaccine, arm became red and swollen at the injection site. Eyes became red and swollen. Experienced coughing if laying flat, had to sleep upright. Symptoms resolved around 12 hours later.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on arms face and chest
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, Chills, Muscle aches, joint pain, headache
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Joint stiffness, Migraine, Pain, Sensitive skin
Clinical narrative: Migraine at 0420 12/24/2020; Body Aches; Joint stiffness; Skin feels hypersensitive especially at injection site.  Took Tylenol and symptoms are better.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Urticaria
Clinical narrative: Pt(I) report swelling, redness, and warmth at the injection site was first noticed in the morning at 6:30 am on 12/24/2020 currently 2.5 inches by 1 5/8 inches. Pt has history of hives. Hive type rash noted on inside of right arm. Hive do not itch.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Pruritus, Rash, Urticaria
Clinical narrative: feel flushed, warm all over, itchy, and an urticarial rash  appeared on her upper chest and arms..  given diphenhydramine 50mg IM x1, methylprednisolone 125mg, famotidine 20mg. felt better and all symptoms improved except for pruritis by 1715 on 12/23. discharged home from emergency room
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Ear pain, Facial pain, Neuralgia
Clinical narrative: Eye dryness progressing to neuropathic type pain localized to the face (left upper face with clear demarcation, same side as injection). At the worst, felt neuropathic pain plus ear pain. Not improved with 1g tylenol and advil. 3 hours later with no improvement, took 10mg prednisone finally offering relief.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Patient states that she started experiencing mild arm soreness shortly after receiving the vaccine. Later that evening, she stated feeling slightly fatigued.  Patient states that she was Covid positive in July. She has not been around anyone with Covid recently and she has no travel history.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness postural, Myalgia, Pyrexia
Clinical narrative: Started with severe myalgias day of evening, the next day grew to include low grade fever Tmax 100.5, severe chills, inability to stand without feeling dizzy. Most sx resolved by this morning (2 days out from shot).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Tremor, Vomiting
Clinical narrative: Nausea Vomiting Shaking Chills Arm soreness