chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 4/16/2021: Vertigo (30 sec.) when laying in bed ( 12:30 PM for about half hour)  and occurred again after I got up. Had not eaten prior and drank a lot of water after and no further incident occurred. I had taken an 1.5 hour walk in the morning. Fatigued  4/17/2021: Vertigo occurred during half hour yoga video session when I laid down on the mat. Approximately 30 seconds.  Discontinued session and rested remainder of the day. No further events. Also drank 7 glasses of water with two cups of tea as I thought I was dehydrated. Fatigued remainder of the day.  4/18/2021: No vertigo but did not exercise and rested all day. Fatigued.  4/19/2021: Vertigo with yoga session twice in the  morning.  Approximately 15-30 seconds. Went to clinic to vaccinate residents and felt tired, but no further events. 4/20/2021: Vertigo occurred three times during yoga. Felt lightheaded after. Went to see primary health care provider at 1:30 PM in person and felt it was BPPV and provided at home instructions. Felt lightheaded in office when I stretched my neck to look up and when I got off of exam table. Vertigo occurred again when I went to lift my head to hang clothes on the line in the afternoon. No appetite. Hydrated again well and did eat. Fatigued remainder of the day.  Nauseated in the evening and vomited due to vertigo.  4/21/2021 Vertigo severe in the morning and dry heaves after I woke up. Unable to attend vaccine clinic this day as I was so unbalanced I had difficulty ambulating. Just rested remainder of day. Could not perform exercises Dr. had suggested for BPPV . Fatigued. 4/22: Slightly  improved through the day. Able to perform some of the exercises Dr. had suggested. 4/23/2021: Felt better. Vertigo lessoned throughout day 4/24.2021: Resolved.  Vertigo lasted for one week.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable consumer (the patient) via a company representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills after getting the Pfizer COVID-19 vaccine. The outcome of chills was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Pruritus, Urticaria
Clinical narrative: Over a period of about 1.5 months, I developed hives all over my body. They started on my chest/upper back and slowly spread throughout. I had no idea what was wrong with me but knew I had reached a breaking point when all I could think about was the itching. I was scratching so much that I was causing deep bruising to form all over my body. Finally I was able to see a dermatologist on 5/3/21 who has started me on a Prednisone regimen and took a couple of skin biopsies while he was at it (still waiting for the results). Three days into treatment, this does seem to be helping.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Nausea, Presyncope, Vomiting
Clinical narrative: Patient began feeling nauseous and lightheaded 5-10 mins post-vaccination and alerted pharmacy staff. Patient vomited shortly after. Pharmacist checked blood pressure which was very low at 60/45. RPh rechecked every 5 minutes getting readings of 67/48, 80/57, 108/82. EMS was called and by arrival BP had returned to normal. Likely due to vagal response, reaction to painful stimuli.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal haemorrhage
Clinical narrative: Hemorrhages of the left eye retina.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage, Headache, Ocular hyperaemia
Clinical narrative: 30 minutes after the vaccine was administered I got a mild headache that lasted most of the day.  Around 3:30 in the afternoon my wife noticed my left eye being red.  It appeared to be burst blood vessels.  I had not been straining or doing any activity that I believe would have facilitated this type of event.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: Swelling, redness and itching at injection site. I believe it is Covid-arm. Also pain in lymph node near arm pit. Fatigue.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination complication
Clinical narrative: Swelling, redness and itching at injection site. I believe it is Covid-arm. Also pain in lymph node near arm pit. Fatigue.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: first covid vaccine and all 3 of them ended up with UTIs; This is a spontaneous report from a Pfizer sponsored program. This consumer reported similar events for three patients. This is the second of three reports. A contactable consumer reported a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included hydrocortisone acetate, neomycin sulfate, polymyxin B sulfate (CORTISPORIN) from an unknown date for an unknown indication. On an unknown date within 24 hours of the vaccine, the patient experienced a urinary tract infection (UTI). The outcome of UTI was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391028 Different patient/ Same AE and suspect product (patient# 1);US-PFIZER INC-2021391051 Same reporter/suspect product/event, different patient.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Nausea, Syncope
Clinical narrative: patient was sitting in a chair in the waiting area the 15 minutes when he fainted from the chair after 12 minutes. was nauseous and light headed still after 5 minutes. call 911 and paramedics checked him out. patient refused to go to hospital. mom took him home
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on face, rash on top of shoulders  all down my back.  Chest and down both arms to elbows. Red Itchy painful rash. Started  one day after first vacc and after second vacc  and had a rash for a total of 8 weeks.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under armpit area of left arm (where shot was administered). Urgent care told me to monitor the area for the next 7-10 days.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Neck pain, Pain in extremity, Swelling
Clinical narrative: After almost 10 days after the injection my neck was in a lot of pain. I couldn?t turn it. Soon afterwards, the whole left side of my neck swelled up including near the clavicle of my neck. My initial symptom after the vaccine was only a sore arm and headache.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 06Apr2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine 06Apr2021 and inquired whether it was safe to take acetaminophen for a headache. The outcome of headache was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy after the second dose of vaccine; This is a spontaneous report received from a contactable nurse (the patient) via a company representative. A patient of an unspecified gender and age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included COVID-19 several months ago. Concomitant medications were not reported. The patient experienced lymphadenopathy after the second dose of vaccine. The outcome of lymphadenopathy was unknown.    No follow-up attempts possible; information about batch/lot number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Cerebral atrophy, Computerised tomogram, Dehydration, Magnetic resonance imaging head
Clinical narrative: Extreme dehydration; Nausea; Vomiting; Severe ataxia; mad global cortical atrophy; This is a spontaneous report from a contactable nurse (patient).   A 70-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6207) at single dose, in the right arm, on 11Mar2021, for COVID-19 immunisation. Relevant medical history included Sjogren's disease form an unspecified date. The patient previously, on 18Feb2021, at 11:45 AM, at the age of 70 years, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6200) at single dose, in the left arm, for COVID-19 immunisation. On 24Feb2021, at 11:00 PM, the patient experienced an unspecified adverse event. Concomitant medications included levothyroxine 112 ug, from an unspecified date, for an unknown indication. On 16Mar2021, mad global cortical atrophy was reported. On 27Mar2021, the patient experienced extreme dehydration, nausea, vomiting and severe ataxia. Physician Office Visit and Emergency Room Visit were required. The patient received on 27Mar2021 normal saline (NS) 2L in ER over 2hr for extreme dehydration, nausea, vomiting and severe ataxia. Relevant laboratory tests included computerised tomogram (CT scan w/o contrast) on 12Mar2021: multifocal to confluent areas of decreased attenuation in the deep white matter ascending into the basal ganglia consistent with mod severe small vessel ischemic/degenerative finalizing; Magnetic resonance imaging head (MRI Brain w/o contrast) on 16Mar2021: no acute findings. Mad global cerebral atrophy and severe renascent small vessel ischemic white matter disease; MRI Neck on 16Mar2021: unremarkable and MRI Head w/o contrast on 18Mar2021: unremarkable. Clinical outcome of the events was unknown at time of this report.; Sender's Comments: Based on the information currently available causality between reported events and suspet product BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging neck, Nausea, Vomiting
Clinical narrative: Extreme dehydration; Nausea; Vomiting; Severe ataxia; mad global cortical atrophy; This is a spontaneous report from a contactable nurse (patient).   A 70-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6207) at single dose, in the right arm, on 11Mar2021, for COVID-19 immunisation. Relevant medical history included Sjogren's disease form an unspecified date. The patient previously, on 18Feb2021, at 11:45 AM, at the age of 70 years, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6200) at single dose, in the left arm, for COVID-19 immunisation. On 24Feb2021, at 11:00 PM, the patient experienced an unspecified adverse event. Concomitant medications included levothyroxine 112 ug, from an unspecified date, for an unknown indication. On 16Mar2021, mad global cortical atrophy was reported. On 27Mar2021, the patient experienced extreme dehydration, nausea, vomiting and severe ataxia. Physician Office Visit and Emergency Room Visit were required. The patient received on 27Mar2021 normal saline (NS) 2L in ER over 2hr for extreme dehydration, nausea, vomiting and severe ataxia. Relevant laboratory tests included computerised tomogram (CT scan w/o contrast) on 12Mar2021: multifocal to confluent areas of decreased attenuation in the deep white matter ascending into the basal ganglia consistent with mod severe small vessel ischemic/degenerative finalizing; Magnetic resonance imaging head (MRI Brain w/o contrast) on 16Mar2021: no acute findings. Mad global cerebral atrophy and severe renascent small vessel ischemic white matter disease; MRI Neck on 16Mar2021: unremarkable and MRI Head w/o contrast on 18Mar2021: unremarkable. Clinical outcome of the events was unknown at time of this report.; Sender's Comments: Based on the information currently available causality between reported events and suspet product BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Hypothermia
Clinical narrative: hypothermia; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8737, second dose) solution for injection intramuscular in the arm on 02Apr2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing Hashimotos from 03Jan2014 and ongoing hypothyroidism from 03Jan2014. Concomitant medications included ongoing levothyroxine for hypothyroidism from 2014 and ongoing liothyronine for Hashimotos from 2019. Historical vaccine included BNT162B2 (first dose, lot EN6199) for COVID-19 vaccination on 12Mar2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 02Apr2021, the patient experienced hypothermia, the patient temperature dropped to 94.79 degree F. Seriousness criteria was important medical event. The patient almost went to ER (emergency room). There was no treatment for the event hypothermia. The outcome of the event hypothermia was recovered in Apr2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: patient inadvertently received an expired dose of TENIVAC with no reported adverse event; Initial information was received on 20-Apr-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 17-year-old male patient who inadvertently received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment(s) and family history were not provided. The patient's past vaccination(s) included DIPHTHERIA TETANUS ACELLULAR PERTUSSIS on 12-FEB-2021. Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 20-Apr-2021, the patient received a first dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6265AA, expiry date-19-Apr-2021) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (on the same day).  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given a 0.5ml, expired, dose of Menactra/no AE; Initial information received on 21-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 11-year-old male patient who was given a 0.5ml, expired, dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; and PHENYLEPHRINE, TROPICAMIDE (T-P).  On 20-Apr-2021, the patient received a dose of 0.5 ml suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6543AA, expiry date-unknown) via an unknown route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day).  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: 29 year old female patient was administered expired dose of TENIVAC, with no adverse event; Initial information received on 27-Apr-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 29 year old female patient who was administered expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 26-Apr-2021, the patient received a 0.5 ml booster dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6265AA and expiry date: 19-Apr-2021) (Frequency: Once) via an intramuscular route at an the deltoid NOS (not otherwise specified) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that this case was placed in proxy as there was no one available during the time of the attempted transfer. A call back is needed for assistance. The caller stated that her previous call was disconnected and is calling back because she wanted to know if there is any data supporting the use of expired TENIVAC. The caller stated that the product expired last week and was administered today. The caller would like to know if the patient must be revaccinated. The TENIVAC was given in the deltoid, but they not sure if it was left or right deltoid. No further information was provided.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Paraesthesia
Clinical narrative: Guillian Barre syndrome; This is a spontaneous case initially received from other non-health professional on 30-Mar-2020, concerning a 44-years-old male patient.  The patient's medical history included borderline diabetes, hypertension and gout.  The patient's concomitant medications included lisinopril and allopurinol both for an unknown indication.    On 14-Feb-2020, the patient was administered Afluria Quadrivalent [influenza vaccine; route of administration: intravenous; anatomical location: deltoid; dose: 0.5 ml, batch number and expiry date: not reported] for influenza prophylaxis.  On 05-Mar-2020, 20 days after vaccination, the patient experienced tingling numbness in legs and hands. Patient was diagnosed with Guillian Barre Syndrome.  On 16-Mar-2020, the patient was admitted to the hospital.  On an unknown day in Mar-2020, the patient was treated with unspecified intravenous immunoglobulins (IVIGs).   On 22-Mar-2020, after six days in hospital, the patient was discharged.   At the time of his case, the outcome of event was not resolved.  The event of 'Guillain Barre syndrome' was considered serious due to criteria of hospitalization and medical significance.   Causality assessment per reporter was not provided.  Company comment: The patient developed Guillain-Barre syndrome 20 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality may have been confounded by treatment with concomitant medication lisinopril. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed Guillain-Barre syndrome 20 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality may have been confounded by treatment with concomitant medication lisinopril. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related (defaults to "related" in the safety database for reporting purposes).
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: High on fever, 108ºF; This spontaneous case was received on 28-Sep-2020 from a pharmacist (reference number SEQW-02494) and concerned a 60-year-old, male patient.  The patient's medical history and concomitant medication deatels were not provided.  On 26-Sep-2020, around 11:00 am, the patient was vaccinated with Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: right arm) for influenza prophylaxis. The batch number reported was 279836, expiration date: 30-Jun-2021.   On the same day, in the afternoon, the patient developed high fever, 108°F and was hospitalized.  On an 28-Sep-2020, reported as today, the patient called to the pharmacy saying that he was discharge from hospital.  The outcome of the event was unknown.  The reporter did not provide causality assessment.  Company comment: The patient developed pyrexia on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient was hospitalized. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).  The reporter assessed the case as serious.; Sender's Comments: The patient developed pyrexia on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient was hospitalized. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, No reaction on previous exposure to drug, Pityriasis rosea, Rash
Clinical narrative: Pityriasis rosea; This spontaneous case was received on 28-Oct-2020 from a physician via Health Authority (reference number: SEQW20-04410) with an additional document received on 29-Oct-2020 (being processed together) and concerned a 62-year-old, female patient.   The patient's past medical history included rash. The patient's current medical history was not provided. The patient's historical vaccine included Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent) received on 22-Oct-2018 with no adverse events. The patient's concomitant medications were not reported.  On 10-Oct-2019, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, indication, dose, route of administration and anatomical location: not reported). The batch number reported was P10019697 (Seqirus batch number: P100109697), expiration date: 22-May-2020.     On an unknown date in 2019, an unknown amount of time after receiving Afluria Quadrivalent, the patient developed rash which was diagnosed as pityriasis rosea by her dermatologist.   The outcome of event was not reported.   The reporter did not provide causality assessment.   This case is linked to case 202005863 (the same patient).  Additional information received on 03-Dec-2020 from physician with additional information (being processed together) received on 07-Dec-2020 via Health Authority (reference number: SEQW20-05538): Historical vaccine from 2018 removed, as it was confirmed that the rash was a month before receiving the flu vaccine. Linked case deleted. Additional reference number added. Narrative was amended accordingly.   Case updated on 15-Apr-2021: Correction made to information received on 03-Dec-2020: Event verbatim and LLT recoded from 'pityriasis' to 'pityriasis rosea', per correction request. Narrative amended accordingly. Company comment updated.  Company comment: The patient experienced pityriasis after administration of Afluria Quadrivalent. Pityriasis rosea is a is a self-limited, inflammatory disease characterized by diffuse, scaling papules or plaques. The cause of pityriasis rosea may be viral infection (some research has implicated human herpesviruses 6, 7, and 8). Drugs may cause a pityriasis rosea-like reaction. Causality is unassessable due to lack of information about reaction onset date.; Sender's Comments: The patient experienced pityriasis after administration of Afluria Quadrivalent. Pityriasis rosea is a is a self-limited, inflammatory disease characterized by diffuse, scaling papules or plaques. The cause of pityriasis rosea may be viral infection (some research has implicated human herpesviruses 6, 7, and 8). Drugs may cause a pityriasis rosea-like reaction. Causality is unassessable due to lack of information about reaction onset date.
Age: 23.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Tenderness
Clinical narrative: A localized reaction with erythema and tenderness in the arm; A localized reaction with erythema and tenderness in the arm; This spontaneous case was received on 11-Dec-2020 via Health Authority (reference number: SEQW20-05719), reported by a physician and concerned a 23-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 04-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847 and expiry date was 30-Jun-2021.  On an unreported date in 2020, after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. The patient did not receive any treatment.  On an unreported date in 2020, within 48h to 72h, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202007626, 202007627 and 202007631 due to the same reporter.  Company comment: A 23-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.; Sender's Comments: A 23-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Loss of consciousness
Clinical narrative: PATIENT FELT LIGHTHEADED IMMEDIATELY AFTER VACCINATON, LOST CONSCIUSNESS 1 MINUTE AFTER VACCINATION, REGAINED CONSCIOUSNESS 10 SECONDS AFTER. BLOOD PRESSURE WAS LOW. PATIENT WAS MONITORED AND BLOOD PRESSURE WAS CHECKED 3 MORE TIMES. PATIENT HAD WATER, SAT WITH FEET RAISED. HE WAS UNDER CLOSE OBSERVATION UNTIL HIS BLOOD PRESSURE RETURNED TO NORMAL AND FELT BETTER. PATIENT LEFT PHARMACY AND I CALLED HIM HOURS TO LATER TO SEE HOW HE FELT, HE REPORTED FEELING FINE.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Tinnitus
Clinical narrative: Extreme tinnitus
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram abnormal, Coronary arterial stent insertion, Coronary artery occlusion, Myocardial infarction
Clinical narrative: patient suffered significant heart attack (100% blockage right coronary artery) on 4/18/2021. He has NO risk factors for coronary artery disease (no HTN, DM, hyperlipidemia, smoking, obesity, family history of CAD). He exercises by swimming one hour 7 days per week.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Haemorrhage, Head injury, Joint injury
Clinical narrative: As patient walked out pharmacy after her 1st moderna vaccine, she felt light-headed and dizzy. She temporarily lost consciousness and felt on the street. She hit her head on something that she can not recall and got injured on her knees causing some bleeding. A random person walking by called 911 for the patient so she got transported to ER immediately.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: As patient walked out pharmacy after her 1st moderna vaccine, she felt light-headed and dizzy. She temporarily lost consciousness and felt on the street. She hit her head on something that she can not recall and got injured on her knees causing some bleeding. A random person walking by called 911 for the patient so she got transported to ER immediately.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Induration, Laboratory test, Lymphangitis, Nodule
Clinical narrative: Began with lump under left armpit 5 days after first vaccine. Followed by tightness in upper left arm following week, continued into lower arm the week after. The following week the whole left arm felt tight.  5 days after 2nd vaccine small lump appeared on lower  left bicep, hardness ran from lump down through crook of elbow.  2nd lump appeared a few days later below hardness trail in the forearm below crook of elbow.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Ultrasound scan abnormal
Clinical narrative: Began with lump under left armpit 5 days after first vaccine. Followed by tightness in upper left arm following week, continued into lower arm the week after. The following week the whole left arm felt tight.  5 days after 2nd vaccine small lump appeared on lower  left bicep, hardness ran from lump down through crook of elbow.  2nd lump appeared a few days later below hardness trail in the forearm below crook of elbow.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest X-ray normal, Chills, Decreased appetite, Dizziness
Clinical narrative: Today's Visit: COVID-19 Pfizer, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (CVX=208)5/2/2021, 4/11/2021 patient received both of her vaccines at clinic Had fatigue and left arm soreness after the first vaccine but this resolved after a few days  Within 8 hours, however, of receiving the second vaccine patient had chills, diaphoresis, tactile temperature and a very sore left arm.  Severe headache and dizziness.  Could not get out of bed for two days.  Poor appetite.  Was able to maintain her hydration.  Beginning on Tuesday had a very painful throat with dysphagia.  Had some breathing.    Seen last night at clinic due to pain and breathing difficulties.Maalox/pepcid and albuterol/decadron.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Fatigue, Full blood count, Full blood count normal
Clinical narrative: Today's Visit: COVID-19 Pfizer, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (CVX=208)5/2/2021, 4/11/2021 patient received both of her vaccines at clinic Had fatigue and left arm soreness after the first vaccine but this resolved after a few days  Within 8 hours, however, of receiving the second vaccine patient had chills, diaphoresis, tactile temperature and a very sore left arm.  Severe headache and dizziness.  Could not get out of bed for two days.  Poor appetite.  Was able to maintain her hydration.  Beginning on Tuesday had a very painful throat with dysphagia.  Had some breathing.    Seen last night at clinic due to pain and breathing difficulties.Maalox/pepcid and albuterol/decadron.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Mobility decreased, Oropharyngeal pain, Pain
Clinical narrative: Today's Visit: COVID-19 Pfizer, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (CVX=208)5/2/2021, 4/11/2021 patient received both of her vaccines at clinic Had fatigue and left arm soreness after the first vaccine but this resolved after a few days  Within 8 hours, however, of receiving the second vaccine patient had chills, diaphoresis, tactile temperature and a very sore left arm.  Severe headache and dizziness.  Could not get out of bed for two days.  Poor appetite.  Was able to maintain her hydration.  Beginning on Tuesday had a very painful throat with dysphagia.  Had some breathing.    Seen last night at clinic due to pain and breathing difficulties.Maalox/pepcid and albuterol/decadron.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Today's Visit: COVID-19 Pfizer, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (CVX=208)5/2/2021, 4/11/2021 patient received both of her vaccines at clinic Had fatigue and left arm soreness after the first vaccine but this resolved after a few days  Within 8 hours, however, of receiving the second vaccine patient had chills, diaphoresis, tactile temperature and a very sore left arm.  Severe headache and dizziness.  Could not get out of bed for two days.  Poor appetite.  Was able to maintain her hydration.  Beginning on Tuesday had a very painful throat with dysphagia.  Had some breathing.    Seen last night at clinic due to pain and breathing difficulties.Maalox/pepcid and albuterol/decadron.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Flurry of unusual toothaches approx 2 weeks after 1st moderna shot, and also ~24 hrs after 2nd moderna shot.  No treatment other than OTC pain meds/NSAIDs, seems to have passed at this point.  Uncertain if related to the vaccine or not; I do have tooth issues but I have not had pain of that sort before. I have been advised to report it regardless so I am.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears ringing; still ongoing month later
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Headache, fever, nausea, chills.  3am 5/4 to 3pm 5/5
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fall, Head injury, Hyperhidrosis
Clinical narrative: After leaving the immunization room, the patient fainted while walking through the store. She hit her head on the floor when she fell. While waiting for the paramedics, she was lightheaded, clammy, pale and sweating.  Paramedics took her to the hospital after initial evaluation in the store.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Syncope
Clinical narrative: After leaving the immunization room, the patient fainted while walking through the store. She hit her head on the floor when she fell. While waiting for the paramedics, she was lightheaded, clammy, pale and sweating.  Paramedics took her to the hospital after initial evaluation in the store.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Coronary artery disease, Coronary artery occlusion, Percutaneous coronary intervention
Clinical narrative: NSTEMI, treated with PCI, DES evidence of multivessel coronary artery disease PCX 100% occluded submitting out of abundance of caution in case vaccine poses risk of clots in coronary artery disease patients
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia
Clinical narrative: PATIENT SAID THAT HER LEFT ARM FELT NUMB FROM THE INJECTION SITE DOWN TO HER FINGER TIPS
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral mucosal blistering, Oral pain
Clinical narrative: Received a blister mouth sore 3 hours later along with breakout around mouth.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I got shingles.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod sting, Chest pain, Flushing, Headache, Injection site pain
Clinical narrative: Second Vaccine shot- 35-45 min flush face and achy muscles 2 hours-body ache and headache  8 hours- body ache/head ach/ fever/ night sweats/ injection site pain 39  hours- chest pain ( went to ER)  4 days out- rash on arm plus all the other listed symptoms  Got stung by several wasps and symptoms getting worse. Taken tylonal and benedryl to no avail.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Night sweats, Pain, Pyrexia, Rash
Clinical narrative: Second Vaccine shot- 35-45 min flush face and achy muscles 2 hours-body ache and headache  8 hours- body ache/head ach/ fever/ night sweats/ injection site pain 39  hours- chest pain ( went to ER)  4 days out- rash on arm plus all the other listed symptoms  Got stung by several wasps and symptoms getting worse. Taken tylonal and benedryl to no avail.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Anaemia, Angiogram pulmonary normal, Aspartate aminotransferase increased, Asthenia
Clinical narrative: Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, C-reactive protein increased, Computerised tomogram thorax, Dyspnoea
Clinical narrative: Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haematocrit decreased, Haemoglobin decreased, Inflammatory marker test, Myositis
Clinical narrative: Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Vaccination complication
Clinical narrative: Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose normal, Dizziness, Feeling jittery, Tremor
Clinical narrative: AFTER PATIENT GOT VACCINE, PATIENT WAITED FOR 15 MINUTES. PT STATED EXPRESSING SHAKINESS, GLITTERY, AND ABOUT FAINT. I RAISED HER LEGS UP AND GAVE HER ORANGE JUICE, PT RESTED HER HEAD AGAINST THE WALL. WITHING 15 MINUTES, PT WAS BACK TO NORMAL.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Fatigue, Injection site urticaria, Nasal congestion, Rhinorrhoea
Clinical narrative: Rash at injection site with hives, anaphylaxis started. I took benadryl and topical cream and used inhaler  Also have extremely runny nose, congestion and fatigue
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hyperhidrosis, Pallor, Paraesthesia, Tinnitus
Clinical narrative: Patient became very pale and whole body sweating. Patient reported ears ringing and black spot in vision. Also, said arms were tingling. lasted approximately 15 minutes
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Patient became very pale and whole body sweating. Patient reported ears ringing and black spot in vision. Also, said arms were tingling. lasted approximately 15 minutes
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Patient called the pharmacy the day after the vaccine stating she had a large bruise around the injection site and there was a bump at the injection site shortly after given. I instructed her to apply ice to the area. I called her back the next day and she stated the bruise was a little darker, but her arm was not as sore anymore.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient mistakenly received the Pfizer COVID Vaccine at age 15, during a time when it was only approved for 16+. Following CDC guidance, the second dose was administered as well. No adverse effects reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Lymphadenopathy, Migraine, Spondylitis
Clinical narrative: Fatigue the day of vaccination, severe arthritis pain in neck, back, hips & knees for several days after vaccination so used Gabapentin and Voltaren, swollen lymph nodes in neck 2 days after vaccination prescribed Azithromycin 250mg dose pk and methylprednisolone 4mg dosepk but did not take latter due to prednisone interaction with Moderna
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Cardiac stress test, Catheterisation cardiac, Computerised tomogram, Electrocardiogram
Clinical narrative: Headache started on crown of head and went from 0-100 in 30 seconds I was on my knees.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head, Magnetic resonance imaging neck, Scan with contrast, Troponin I increased
Clinical narrative: Headache started on crown of head and went from 0-100 in 30 seconds I was on my knees.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site pain, Pain
Clinical narrative: pt reports having throbbing/sore arm on 4/30/21, then on 5/5/21 has sore arm after mowing, when touches injection site (site of soreness) there is blood. There is enough blood to cover hand.  Pt reports having no blood disorders.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse events happened its age adminstration error
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Migraine, Swelling face
Clinical narrative: Facial swelling and extreme flushing of the face neck and arms.  Headache turned to migraine with in two days.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster, Ophthalmic herpes zoster, Tinnitus, Visual impairment
Clinical narrative: Patient described brain fog. Tinnitus progressing to hearing crickets and then hearing the ocean. Patient broke out in shingles, this time affecting the eye and losing partial eye sight (had visit with eye doctor recently). Has follow up regarding tinnitus with healthcare provider soon. First Shingrix dose was November 13, 2020.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Influenza
Clinical narrative: I had the worst possible flu symptoms including headache, body aches, uncontrollable shivers, lethargy, and reduced appetite that lasted about 5 days.  Since then, I have had Vertigo joint and muscle pain, tremors in my extremities (mostly hands) and occasional blurry vision.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Pain, Tremor, Vertigo
Clinical narrative: I had the worst possible flu symptoms including headache, body aches, uncontrollable shivers, lethargy, and reduced appetite that lasted about 5 days.  Since then, I have had Vertigo joint and muscle pain, tremors in my extremities (mostly hands) and occasional blurry vision.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: I had the worst possible flu symptoms including headache, body aches, uncontrollable shivers, lethargy, and reduced appetite that lasted about 5 days.  Since then, I have had Vertigo joint and muscle pain, tremors in my extremities (mostly hands) and occasional blurry vision.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Periodic sharp pain and aching on vaccine site; persistent and near-constant fatigue since second dose
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Miliaria, Paraesthesia, Pruritus
Clinical narrative: Within minutes, my fingers felt prickly, then flushing of face,  neck and chest; a prickly heat. Continued redness and slight itchiness on neck hours after onset.   No fever.  I?m reporting this while it is still an ongoing event
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling of left upper arm  for 6 weeks persistent and affecting quality of life
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site urticaria, Pain
Clinical narrative: Headache within the first 2 hours of 1st dose given. The headache lasted the first 12 hours. Also, feeling a little achy all over my body, as well as a slightly sore arm day of vaccine. Day 2, a red welt appeared (the size of a quarter) next to injection site. Arm became even more intensely sore the second day.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore .  Very aggressive.  Course was about 7 days.  Then  Felt first stages of recurrence of another cold sore 10 days after second shot.  Have over the counter medicine on hand so seemed to stop it.  However, I only get cold sores less than once a year so timing suggests a connection.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy, Appendicitis, Blood test, Computerised tomogram, Laparoscopic surgery
Clinical narrative: Two day later..beginnings of symptoms ..of what would turn out to be...Appendicitis...     shot on Thurs ..Appendicitis symptoms late morning Sat        Emergency Appendectomy...Mon Eve