chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Pain, Pyrexia
Clinical narrative: 3 days of fever; 7 days of feeling hurt, "nasty" and bad; 7 days of feeling hurt; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included post herpetic neuralgia and antiviral regimen.   On 16th November 2020, the patient received the 1st dose of Shingrix. On 17th November 2020, 1 days after receiving Shingrix, the patient experienced fever, pain and malaise. On 20th November 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain and malaise were recovered/resolved.   It was unknown if the reporter considered the fever, pain and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced fever, malaise and feeling hurt, nasty and bad. 1 week before vaccination, patient was on antiviral medication for post herpetic neuralgia. At the time of reporting, patient still had post herpetic neuralgia. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Herpes zoster, Rash
Clinical narrative: Shingles caused by the Shingrix vaccine; Felt pain under her arm; Felt pain / on her breast; Rash that appeared on her chest and back; This case was reported by a consumer and described the occurrence of axillary pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th November 2020, 1 days after receiving Shingrix, the patient experienced axillary pain, breast pain, rash and shingles. On an unknown date, the outcome of the axillary pain, breast pain and rash were recovered/resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the axillary pain, breast pain and rash to be related to Shingrix. The reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 69 years or 70 years. The patient reported that, she felt pain under her arm and on her breast.  The Pain developed into a Rash that appeared on her chest and back.  She stated that it disappeared after five weeks.  The patient stated that she had shingles caused by the Shingrix vaccine. Consented to follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: As the vaccine provider removed the syringe, a drop of clear liquid on arm; As the vaccine provider removed the syringe, a drop of clear liquid on arm; A spontaneous report was received from a consumer, concerning a 30-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and as the vaccine provider removed the syringe, a drop of clear liquid was on her arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 and as the vaccine provider removed the syringe, a drop of clear liquid was on her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The events, as the vaccine provider removed the syringe a drop of clear liquid was on her arm, was considered resolved on 04 Feb 2021.; Reporter's Comments: This case concerns a 30-year-old female who experienced a NS unexpected event of Incomplete dose administered after a drop from the syringe dripped onto her arm.  The event occurred with the first dose of mRNA-1273. No associated adverse events were reported. Event considered resolved. This report refers to a case of PT Incorrect dose administered for mRNA-1273 (lot # unknown) with no associated adverse events.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Incorrect dose administered, Lethargy, Vaccination site erythema
Clinical narrative: Inflamed; lethargic; a little light headed; tired; when the shot was done, dripping of the vaccine liquid leaked from the arm; warm and red area about 3 centimeters around injection site; warm and red area about 3 centimeters around injection site; swelling on arm; A spontaneous report was received from a consumer concerning a 64 year old, female patient who experienced  injection site warmth, injection site erythema, injection site swelling, injection site inflammation, fatigue, lethargy, dizziness and incorrect dose given.     The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 12-JAN-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, injection site warmth, injection site erythema, injection site swelling, injection site inflammation, fatigue, lethargy, were not reported. The outcome of the event, incorrect dose given, was resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 64-year-old female who had NS unexpected lethargy, dizziness, injection site warmth, injection site inflammation, and incorrect dose administered (liquid leaked from arm), and NS expected injection site redness, injection site swelling, and fatigue.  The events occurred the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Inflamed; lethargic; a little light headed; tired; when the shot was done, dripping of the vaccine liquid leaked from the arm; warm and red area about 3 centimeters around injection site; warm and red area about 3 centimeters around injection site; swelling on arm; A spontaneous report was received from a consumer concerning a 64 year old, female patient who experienced  injection site warmth, injection site erythema, injection site swelling, injection site inflammation, fatigue, lethargy, dizziness and incorrect dose given.     The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 12-JAN-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, injection site warmth, injection site erythema, injection site swelling, injection site inflammation, fatigue, lethargy, were not reported. The outcome of the event, incorrect dose given, was resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 64-year-old female who had NS unexpected lethargy, dizziness, injection site warmth, injection site inflammation, and incorrect dose administered (liquid leaked from arm), and NS expected injection site redness, injection site swelling, and fatigue.  The events occurred the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 1 week early; A spontaneous report  was received from a health care professional concerning a 38 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and received a second dose 1 week early (inappropriate scheduling of vaccine administered).      The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A) on 13-JAN-2021.  On 03-FEB-2021, approximately the patient received their second of two planned doses of mRNA-1273 (Batch number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.    The patient received the second dose 1 week early from 28 day recommendation.  Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The event, second dose 1 week early, was considered resolved/recovered.; Reporter's Comments: This report refers to a case of inappropriate scheduling of vaccine administered for mRNA-1273 (Batch number: 025J20-2A) with no associated AEs.
Sex: M
Vaccine: FLUX
Symptoms: Flatulence, Gait disturbance, Mobility decreased
Clinical narrative: Cannot walk; Cannot move arms; Still ill with gas; Initial information received on 14-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (reference number: US-SA-SAC20210202000763).  This case involves a 69-year-old male patient who experienced cannot walk (gait disturbance), cannot move arms (mobility decreased) and still ill with gas (flatulence), while he received INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose (double) of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious cannot walk (gait disturbance), cannot move arms (mobility decreased) and still ill with gas (flatulence) (unknown latency) following the administration of INFLUENZA VACCINE.   The patient was hospitalized for these events for 90 days (in hospital 3 months).  It is also reported, the patient was rest home over a month.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for cannot walk and cannot move arms and not recovered for still ill with gas (going on 5 months now).  Information on the batch number was requested.; Sender's Comments: This case concerns 69-year-old male patient who experienced gait disturbance, mobility decreased and flatulence after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: RAB
Symptoms: Anaphylactic reaction
Clinical narrative: severe anaphylaxis; Initial information received on 09-Feb-2021 regarding an unsolicited valid serious case received from a physician.  This case involves female patient who experienced anaphylaxis (anaphylactic reaction), while she received vaccine RABIES VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect RABIES VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  The patient developed a serious severe anaphylaxis (anaphylactic reaction) (unknown latency) following the administration of RABIES VACCINE. This event was assessed as medically significant.  The reaction happened in the mid-90's (patient believes it may have been 1996 but is unsure the exact year), and now presented to see if we could determine the component of the vaccine that may have caused the reaction. Patient had contacted multiple people at the university and involved with Rabies Vaccination program, and they are unsure which rabies vaccine would have been given. Patient feels, it was likely Imovax, but this is not certain. If she able to determine which vaccine the patient received, only can test the relevant components. This is particularly relevant for her now as she is interested in COVID vaccination, and want to confirm that the rabies vaccine she received in the past did not contain polyethylene glycol (PEG)/polysorbates [what are thought to be the allergenic components in the messenger ribonucleic acid (mRNA) COVID vaccines]. None of the current Rabies vaccines contains these ingredients to my knowledge, but she want to confirm with the manufacturer that prior formulations did not include them either.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for anaphylactic reaction.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a female patient presented with anaphylactic reaction after vaccination with RABIES VACCINE (unknown manufacturer). The time to onset is unknown. Medical history, concomitant medication, lab data ruling out alternative etiologies would be needed for complete assessment. Based upon the reported information role of an vaccine cannot be assessed.
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness; Swelling; Itching; This spontaneous case was received on 07-Jan-2021 from Med Communications (reference number: SEQW21-00089), reported by other non-health professional (consumer) and concerned a female patient of unreported age.  The patient's medical history included allergy to polyethylene glycols (PEG). The patient's concomitant medications were not reported.   On an unspecified date in Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; anatomical location, dose, route of administration: not reported) for flu prevention. The batch number was not reported.   On an unspecified date, 30 hours after receiving Flucelvax Quadrivalent, as reported, the patient developed swelling, redness and itching.   The outcome of the events was not reported.  The reporter assessed the events as related to Flucelvax Quadrivalent. As reported, the patient had mild adverse reaction to Flucelvax Quadrivalent.  The reporter assessed the case as non-serious.  Company comment: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. On an unspecified date, 30 hours after receiving Flucelvax Quadrivalent, the patient developed swelling, erythema and pruritus. Causal role of the suspect vaccine is assessed as possibly related.; Reporter's Comments: Consumer inquires if Flucelvax Quad contains PEG. She wants to know because she is allergic to it, but on November she got Flucelvax Quad and she only had a mild adverse reaction (swelling, redness and itching).; Sender's Comments: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. On an unspecified date, 30 hours after receiving Flucelvax Quadrivalent, the patient developed swelling, erythema and pruritus. Causal role of the suspect vaccine is assessed as possibly related.
Sex: F
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was received on 08-Jan-2021 from physician via Med Communications (reference number: SEQW21-00113) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported.   On 25-Oct-2018, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, indication and anatomical location: not reported). The batch number reported was 252659 and expiry date was 31-May-2019.  On an unspecified date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed rash.  The outcome of the event was not reported.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  This case is linked with cases 202100472 and 202100473 (the same patient).  Company comment: The event of 'rash' is considered as related to Flucelvax Quadrivalent.; Sender's Comments: The event of 'rash' is considered as related to Flucelvax Quadrivalent.
Sex: F
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Allergic to thiomersal; Rash; This spontaneous case was received on 08-Jan-2021 from physician via Med Communications (reference number: SEQW21-00113) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported. The patient's past vaccinations included Flucelvax Quadrivalent on 25-Oct-2018 and Afluria Quadrivalent on 04-Oct-2019 for flu prevention, after which the patient developed rash both times.  On 24-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 flu prevention. The batch number was not reported.  On an unspecified date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed rash and discovered that she was allergic to thiomersal.   The outcome of the events was not reported.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  This case is linked with cases 202100471 and 202100472 (the same patient).  Company Comment: A female patient of an unknown age developed allergy to chemicals (reported as allergic to thiomersal) and rash after vaccination with the suspect product, Flucelvax Quadrivalent. There is lack of information regarding the vaccination date and events onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Although chronology is unclear, causality of the suspect product cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A female patient of an unknown age developed allergy to chemicals (reported as allergic to thiomersal) and rash after vaccination with the suspect product, Flucelvax Quadrivalent. There is lack of information regarding the vaccination date and events onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Although chronology is unclear, causality of the suspect product cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).
Sex: F
Vaccine: FLUC3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives generalized all over her body; Allergic reaction; This spontaneous case was received on 08-Jan-2021 from other non-health professional (consumer) via Med Communication (reference number: SEQW21-00106) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported.  On an unspecified day in Feb-2018, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified day in Feb-2018, four hours after receiving Flucelvax Qudrivalent, the patient had hives generalized all over her body. The patient experienced an allergic reaction. It was not anaphylaxis. The patient was treated with Benadryl (diphenhydramine hydrochloride) and the reaction was resolved within 24 hours. The reporter wanted to know what was the ingredient that caused the allergic reaction.  On an unspecified date in Feb-2018, the patient was recovered from the events.  The reporter assessed the events as related to Flucelvax Quadrivalent.  The case was assessed as non-serious.  Company comment: The events of allergic reaction and 'hives' are assessed as related to Flucelvax Quadrivalent.; Reporter's Comments: The reporter wanted to know what was the ingredient that caused the allergic reaction.; Sender's Comments: The events of allergic reaction and 'hives' are assessed as related to Flucelvax Quadrivalent.
Sex: F
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Rash, but it was hardly a rash at all; This spontaneous case was received on 13-Jan-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-00170) and concerned a female patient of an unspecified age.  The patient's concurrent conditions included many allergies and eczema. The patient's concomitant medications were not reported.   On an unspecified date in Jan-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose; 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On an unspecified date in Jan-2021, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced rash, but it was hardly a rash at all.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.  This case as assessed as non-serious.  Company comment: The event of 'rash' is considered as related to Flucelvax Quadrivalent.; Sender's Comments: The event of 'rash' is considered as related to Flucelvax Quadrivalent.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal mass, Sensation of foreign body
Clinical narrative: Lump in her throat; This spontaneous case  was received on 13-Jan-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-00155) and concerned a 46-year-old, female patient.  The patient's concurrent conditions included anxiety disorder. The patient's concomitant medications were not reported. The patient stated she had influenza vaccines before and never had an issue.  On 03-Jan-2013, the patient was vaccinated with Afluria (TIV) (influenza vaccine; route of administration, anatomical location, dose: not reported) as prevention of seasonal influenza. The batch number was not reported.  On the same day, after receiving Afluria (TIV), the patient experienced a lump in her throat. The patient stated she had no swelling in her throat and was able to breath. Moreover, the patient stated she did not experience any anaphylactic shock and had no other complications.  On an unspecified date, three and a half months after receiving Afluria (TIV), the patient was still experienced "a lump in her throat".  On an unspecified date, the patient visited emergency room (ER), and had blood oxygen level and blood pressure measured, and results were all good. The patient also stated she is going to consult with an allergist and requested to be provided the ingredients of the Afluria (TIV) vaccine.  At the time of initial reporting, the patient had not recovered from the event.   The reporter did not provide a causality assessment, but the patient stated she was not sure if the above experienced adverse event is related to her anxiety disorder or not.  The case was assessed as non-serious.  Company Comment: A 46-year-old, female patient developed a pharyngeal mass on the same day after vaccination with the suspect product Afluria (TIV). More information regarding the related diagnostic findings is needed. Due to plausible time relationship, causality of the suspect product cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A 46-year-old, female patient developed a pharyngeal mass on the same day after vaccination with the suspect product Afluria (TIV). More information regarding the related diagnostic findings is needed. Due to plausible time relationship, causality of the suspect product cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).
Age: 26.0
Sex: F
Vaccine: FLUC3
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This is a spontaneous case was received on 18-Jan-2021, reported by other non-health professional to Med Communications (reference number: SEQW21-00213) and concerned a 26-year-old, female patient.  The patient's concurrent conditions were not reported. The patient was not taking any concomitant medications.  On 26-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location and route of administration: not reported) for flu prophylaxis. The batch number reported was 283849 and expiry date reported was 30-Jun-2021.  On the same day, after receiving Flucelvax Quadrivalent, reported as ever since, the patient had been suffering from headaches and nausea.   On an unspecified date, the patient visited numerous medical specialists and underwent tests in search of a root cause. The patient's father stated she had done tons of blood works, cat scan of the brain and the pelvis. The treatment measures included steroids and migraine medicines.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.  Company comment: The events of nausea and headache are assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of nausea and headache are assessed as related to Flucelvax Quadrivalent
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Flushing
Clinical narrative: Flush feeling all over body; Lightheaded; Weak; This spontaneous case was received 19-Jan-2021 from other non-health professional (consumer) via Pfizer (reference number: 2020502909) and concerned a female patient of an unreported age.   The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies.  On an unspecified date in 2018, the patient was vaccinated with Afluria (TIV) (influenza vaccine; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date in 2018, immediately after receiving Afluria (TIV), the patient was lightheaded, weak and had flush feeling all over her body. The patient went to the hospital, sat in the waiting room for about 30 minutes and symptoms went away totally. The patient did not require treatment.    On the same day, the patient recovered from the events.  The reporter did not provide causality assessment. The patient hadn't had a flu shot since per her doctor's advice. The patient wanted to get Pfizer-Biontech COVID-19 Vaccine, and she wanted to know what ingredients Afluria TIV and Pfizer-Biontech COVID-19 Vaccine might have in common.   The case was assessed as non-serious.  Company comment:The patient developed flushing, dizziness and asthenia on the same day after receiving Afluria (TIV). Chronology is suggestive. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed flushing, dizziness and asthenia on the same day after receiving Afluria (TIV). Chronology is suggestive. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Sex: U
Vaccine: FLUC3
Symptoms: Gingival pain, Toothache
Clinical narrative: Pain to gums and teeth; Pain to gums and teeth; This spontaneous case from was received on 25-Jan-2021 from non-heath professional (consumer) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On the same day, a few hours after receiving Flucelvax Quadrivalent, the patient experienced pain in gums and teeth.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  Company Comment: A of an unreported age and gender developed toothache and gingival pain on the same day after vaccination with the suspect product, Flucelvax Quadrivalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to lack of information, causality for the reported events is unassessable.; Sender's Comments: A of an unreported age and gender developed toothache and gingival pain on the same day after vaccination with the suspect product, Flucelvax Quadrivalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to lack of information, causality for the reported events is unassessable.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site rash, Mobility decreased, Pain, Pyrexia
Clinical narrative: First dose - fever, severe headache, achy. 2 weeks later - rash on face and then injection site. 3 weeks later - rash on face and then injection site again. Second dose - fever but NO headache, extreme exhaustion, and achy to the point where I could not even brush my hair. Rash at injection site and all over arm.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: First dose - fever, severe headache, achy. 2 weeks later - rash on face and then injection site. 3 weeks later - rash on face and then injection site again. Second dose - fever but NO headache, extreme exhaustion, and achy to the point where I could not even brush my hair. Rash at injection site and all over arm.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Sore arm, headache, nausea, sweats Time: from 7PM (Feb. 17th) until morning of the second day (Feb. 19th).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy uterus, Blood test, Blood urine present, Dysuria, Urine analysis
Clinical narrative: Pain and difficulty urinating, large amount of blood in urine, continuing for 40 hours.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Patient had an Allergic Reaction  unknown cause . Onsite EMS was called vitals were taken BP 157/96 100% O2 room air  HR 92. Patient treated, transported by the EMS to the hospital.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dehydration, Foaming at mouth, Hypercalcaemia, Respiratory tract congestion
Clinical narrative: on 2/13 at 7:30am resident was observed congested, foaming at the mouth. transferred to the  hospital, verbal report from hospital nurse stated the resident was admitted for hypercalcemia and dehydration.   The resident expired on 2/14/21 at 9:30am.    Died on 2/14/2021
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: sore at site of injection with circle of red skin about 4 inches in diameter  fading slightly by 3rd day (today) area is hard and skin sensitive to touch  No other symptoms
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen Arm with intense pain, Extreme Headache, 102 Fever, body weakness, extreme fatigue
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swollen Arm with intense pain, Extreme Headache, 102 Fever, body weakness, extreme fatigue
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Computerised tomogram, Magnetic resonance imaging, Neurological symptom, Pain in extremity
Clinical narrative: 1st day sore arm, 4th day-stroke like reaction, had to go to er
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Whole body scan
Clinical narrative: 1st day sore arm, 4th day-stroke like reaction, had to go to er
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Muscle swelling
Clinical narrative: Swelling and discomfort in muscle that received injection
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Insomnia
Clinical narrative: Soreness at injection site beginning ~2 hours after administration and lasting ~5 days. Chills beginning ~12 hours after injection and lasting ~12 hours, with low-grade fever. Tachycardia beginning ~16 hours after injection and lasting ~16 hours. Insomnia beginning ~16 hours after injection and lasting ~12 hours. Headache beginning ~16 hours after injection and lasting ~12 hours. Malaise and muscle/joint soreness beginning ~16 hours after injection and lasting ~24 hours. Fever and soreness responded to ibuprofen (800 mg PO every 8?10 hours). All adverse effects with the exception of soreness at the injection site resolved completely within ~24 hours of onset (~36 hours after administration).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia, Tachycardia
Clinical narrative: Soreness at injection site beginning ~2 hours after administration and lasting ~5 days. Chills beginning ~12 hours after injection and lasting ~12 hours, with low-grade fever. Tachycardia beginning ~16 hours after injection and lasting ~16 hours. Insomnia beginning ~16 hours after injection and lasting ~12 hours. Headache beginning ~16 hours after injection and lasting ~12 hours. Malaise and muscle/joint soreness beginning ~16 hours after injection and lasting ~24 hours. Fever and soreness responded to ibuprofen (800 mg PO every 8?10 hours). All adverse effects with the exception of soreness at the injection site resolved completely within ~24 hours of onset (~36 hours after administration).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Sensation of swollen tongue
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Pain, Photophobia
Clinical narrative: Excruciating left side of face/head pain. In jaw, neck, face, above and around eye. Extreme  sensitivity to light and sound. Began around 19:00. Tried OTC Motrin and Tylenol with no relief. Tried Orajel since the pain felt similar to maybe a toothache but have had no teeth issues. No relief from anything. Pain was 9/10. Around 5am pain completely went away. No more issues since then.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: 2/11/21:sore arm 2/12/21: swollen lymph glands in neck, slight sore throat, in evening fever 100.6 F maximum 2/13/21: swollen lymph glands in neck, slight sore throat, afebrile, generalized rash over trunk and anticubital area 2/14/21: swollen lymph glands in neck, slight sore throat, afebrile, rash mostly faded 2/15/21 to 2/18/21 swollen glands in neck, slight sore throat, afebrile, no rash 2/19/21 (today): swollen lymph glands in neck, slight sore throat (improving), afebrile, no rash
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: 2/11/21:sore arm 2/12/21: swollen lymph glands in neck, slight sore throat, in evening fever 100.6 F maximum 2/13/21: swollen lymph glands in neck, slight sore throat, afebrile, generalized rash over trunk and anticubital area 2/14/21: swollen lymph glands in neck, slight sore throat, afebrile, rash mostly faded 2/15/21 to 2/18/21 swollen glands in neck, slight sore throat, afebrile, no rash 2/19/21 (today): swollen lymph glands in neck, slight sore throat (improving), afebrile, no rash
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Feeling hot, Full blood count, Heart rate abnormal, Memory impairment
Clinical narrative: I was shadowing another interpreter on Jan. 11, 2021  and started to feel warm, nausea. I sat down and the PA asked if I was ok and then I don't remember anything. I then fainted and my Heart rate was 30 and they called a code blue. They took me to the ER and ran test and gave me IV and everything came back normal.  After that incident, there was at least two other times I had to sit down because I was getting all the same symptoms again and thought it would happen again.  I did donate blood on January 8. I was feeling fine when prior and the following two days.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Syncope, Urine analysis
Clinical narrative: I was shadowing another interpreter on Jan. 11, 2021  and started to feel warm, nausea. I sat down and the PA asked if I was ok and then I don't remember anything. I then fainted and my Heart rate was 30 and they called a code blue. They took me to the ER and ran test and gave me IV and everything came back normal.  After that incident, there was at least two other times I had to sit down because I was getting all the same symptoms again and thought it would happen again.  I did donate blood on January 8. I was feeling fine when prior and the following two days.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site joint movement impairment, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Delayed cellulitis-like reaction/rash (delayed edema & erythema, pruritus at injection site lasting 5+ days, tenderness of injection site lasting 5+ days, pain and limited mobility of shoulder joint on side of injection, malaise & lethargy, mild posterior auricular lymph node swelling & tenderness)
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Lethargy, Lymph node pain, Lymphadenopathy, Malaise
Clinical narrative: Delayed cellulitis-like reaction/rash (delayed edema & erythema, pruritus at injection site lasting 5+ days, tenderness of injection site lasting 5+ days, pain and limited mobility of shoulder joint on side of injection, malaise & lethargy, mild posterior auricular lymph node swelling & tenderness)
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: A sort of tingling in chest and arms.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Approximately 40 minutes following the injection, I experienced an increase in heart rate.  Not painful but noticeable.  Stopped activity and returned to normal within 30 minutes
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient inadvertently received 1st dose of Moderna and 2nd dose of Pfizer.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Shot on Feb 9 - Arm had a knot below injection site that was about 2 ? below injection site and red the next day. Soreness, swelling and redness went away about 4 days later. However, some swelling, itching and redness returned on Feb 17 and continues today.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Pruritus, Sensation of foreign body, Vision blurred
Clinical narrative: Within a couple minutes I began having tingling of my chin that worked up to my forehead. My throat felt like I had a lump in it. I felt off like I may pass out. My vision seemed a little blurry. This lasted about an hour. I felt itchy all over my body. This lasted for several hours.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: ? of shaking chill
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Epididymitis, Urinary tract pain, White blood cells urine positive
Clinical narrative: Signs/Symptoms: Urinary tract pain, WBC's in urine, bilateral epididymitis, 101.2 fever (1/30 to 2/3), chills, no bacterial/other infection identified on urinalysis or culture. Treatment: Rocephin, azithromycin, cipro
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache
Clinical narrative: Patient developed headache ~20 minutes after vaccine administration. Vitals at 11:28 AM: O2 98%, HR 91,   BP 156/85. Vitals at 11 41 AM: O2 99%, HR 90, BP 149/90. Patient reported feeling anxious given her history of anaphylaxis to peanuts. Patient was monitored for 60 minutes. She did not develop any new  or worsening symptoms throughout 60 minute observation period and she remained well appearing throughout.   Reviewed s/sx anaphylaxis (facial swelling, throat itching or tightness, shortness of breath, vomiting)   and advised her to call 911 immediately if these occur today.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, body aches/pains, fever, sore arm
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on the neck, breast and torso .
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Haemorrhage, Thrombosis, Vomiting
Clinical narrative: I started bleeding on the 4th, doctor stated threaten miscarriage. I had blood clots and vomiting'. I was taking to emergency room. I was giving a DNC because I had a miscarriage.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Patient experienced nausea. consulted with NPdid vitals o2 98% hr 94 hx of afib bp 146/91; patient   was feeling fine stayed 30 minutes had caregiver with her to drive home
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Mild arm pain appeared immediately. From 12am - 4am I experience severe chills (despite putting on multiple layers and blankets) that caused me shiver so severely I felt like I was convulsing. No position was comfortable when lying down and nothing made the chills better. I also felt dehydrated, which is unusual for me. From 4am - 6:30am the symptoms reversed and I got extremely hot and uncomfortable. At 8am I noticed a prominent red, warm patch of  swelling around the injection site.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Mild arm pain appeared immediately. From 12am - 4am I experience severe chills (despite putting on multiple layers and blankets) that caused me shiver so severely I felt like I was convulsing. No position was comfortable when lying down and nothing made the chills better. I also felt dehydrated, which is unusual for me. From 4am - 6:30am the symptoms reversed and I got extremely hot and uncomfortable. At 8am I noticed a prominent red, warm patch of  swelling around the injection site.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cellulitis, Computerised tomogram head, Gingival swelling, Swelling face
Clinical narrative: Beginning on 2nd day after 2nd vaccination (on 2/13/21), I experienced swelling in my upper right gum area.  I presumed it was a tooth abscess.  Swelling significantly increased over next two days.  Finally had dental appointment on Monday, 2/15/21.  Dentist determined it was probably NOT an abscess.  He sent me to ER for an antibiotic IV drip.  After labs and CT scan of my head I was diagnosed with cellulitis.  I had an IV drip of antibiotic clindamycin for 4 hours and was sent home with 7 day prescription of oral clindamycin and 3 day presciption of ibuprofen.  Over next two days (2/16-2/17) face swelling diminishedas of today (2/19) it's not completely gone.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Severe neuropathy pain throughout day after.  Gabapentin was ineffective, so took 800mg ibuprofen twice during the day.   Back to normal the following day.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal discomfort
Clinical narrative: Within a half hour my face went numb. More so from the top of my to my forehead. Neck felt like I was in a car accident. Medical Director at the site said extreme rare, but should go away in 24 hours that was Wednesday night. Friday morning still numb.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Dizziness, Fear, Hypopnoea, Respiratory rate increased
Clinical narrative: Patient arrives to obs; PT states patient felt lightheaded.  Patient reports feeling high, VS 212/98,C   127, 100% frightened breathing shallow and quickly. Emotional support given, transported to stretcher.  BP   189/104 hr 105 99% awake and alert.  Continues to repot lightheadedness.  She states walking down from vaccination she had an aura type experience.  10:50 BP 214/97HR 104, 99%, Respiratory arrived.   Followed by MD and IV nurse.  10:55  213/88 HR92 99%.  Transferred to ER by IV Nurse and administrator.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After receiving the vaccine or states he began to feel faint. Pt and Pt?s mother state this happens when he has blood drawn. Pt was seated in a wheelchair and moved to the exam area. Pts vitals are stable. Pt states he is feeling better and would like to leave. Pt?s mother states she is comfortable with leaving. Pt did not require transport to hospital.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Flared up rhumatism and muscle disease. Muscles swollen and achy, still snd hard to move. Chills. Site of injection swollen sore and the impression on bandaid on arm. Told to take mefication dicoflenic. No help. All doctors outof office on Friday
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle disorder, Muscle swelling, Myalgia, Rheumatic disorder
Clinical narrative: Flared up rhumatism and muscle disease. Muscles swollen and achy, still snd hard to move. Chills. Site of injection swollen sore and the impression on bandaid on arm. Told to take mefication dicoflenic. No help. All doctors outof office on Friday
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: fever 100-101 forabout 6 -12hr overall body aches, chills, intermittent for 18 hr headache 24 hr sore left arm 18 hr
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Pyrexia, Tremor
Clinical narrative: Fever 102.5 with shaking chills and abdominal cramps
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Oropharyngeal pain, Pain, Sleep disorder
Clinical narrative: 1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (typically 125/80) the next day.  2. Also that night, I had significant body aches (joints and muscle) that was strong enough to effect my sleep.  3. I developed a sore throat 3 days post vaccine that persisted approximately 2-3 days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Vision blurred
Clinical narrative: Blurred vision and inability to focus right after the vaccine. Still experiencing blurred vision.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Headache, Injection site pain, Ocular discomfort
Clinical narrative: Severe Headache; extremely scratchy eyes, Fever; Fatigue; Site pain; Body aches; Slightly disorientated, for about 24-48 hours
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Severe Headache; extremely scratchy eyes, Fever; Fatigue; Site pain; Body aches; Slightly disorientated, for about 24-48 hours