chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV, PNC13, PPV
Symptoms: Vaccination failure
Clinical narrative: The patient reported that her doctor told her that she has a condition called bronchiectasis; COPD; Emphysema; Bronchitis; but still got Pneumonia in December 2015; pneumonia; This spontaneous report was received from a female patient of unknown age via Pfizer (manufacturer control number 2016076426), referring to herself. The patient never smoked. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.     In February 2015, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Lot#, expiration date, strength, dose and route of administration were not reported) for prophylaxis.   On an unknown date, the patient experienced chronic obstructive pulmonary disease (COPD), emphysema and bronchitis.   On 22-DEC-2015, the patient experienced pneumonia.   At the reporting time, the outcome of COPD, emphysema, bronchitis and pneumonia was not reported.   The causal assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  Follow up information was received from the patient on 28-MAR-2016. The patient reported that her doctor told her that she had a condition called bronchiectasis, on an unspecified date. She also reported that she would be getting a computarised tomography scan of her lungs on a future (unspecified date).   Follow up information was received from the patient on 25-JAN-2021. The patient reported receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in February 2015 but still got pneumonia in December 2015 (vaccination failure). The patient provided permission to contact her current nurse practitioner but stated this was not the person who administered the vaccine in 2015.
Sex: F
Vaccine: PPV, PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: The patient reported that her doctor told her that she has a condition called bronchiectasis; COPD; Emphysema; Bronchitis; but still got Pneumonia in December 2015; pneumonia; This spontaneous report was received from a female patient of unknown age via Pfizer (manufacturer control number 2016076426), referring to herself. The patient never smoked. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.     In February 2015, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Lot#, expiration date, strength, dose and route of administration were not reported) for prophylaxis.   On an unknown date, the patient experienced chronic obstructive pulmonary disease (COPD), emphysema and bronchitis.   On 22-DEC-2015, the patient experienced pneumonia.   At the reporting time, the outcome of COPD, emphysema, bronchitis and pneumonia was not reported.   The causal assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  Follow up information was received from the patient on 28-MAR-2016. The patient reported that her doctor told her that she had a condition called bronchiectasis, on an unspecified date. She also reported that she would be getting a computarised tomography scan of her lungs on a future (unspecified date).   Follow up information was received from the patient on 25-JAN-2021. The patient reported receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in February 2015 but still got pneumonia in December 2015 (vaccination failure). The patient provided permission to contact her current nurse practitioner but stated this was not the person who administered the vaccine in 2015.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: never took her back for the second dose;   This literature marketed report as received from an other health professional referring to a female patient of unknown age. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.       On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot #, expiration date, route and dose details were not provided) for prophylaxis.         The patient's mother had never taken the patient back for the second dose of vaccine as there was so much going on it had been forgotten about long enough (inappropriate schedule of product administration).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions by a pharmacist. Subsequent to the inoculation (date not reported), the patient was treated by health providers for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; other zoster-related conditions; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by health providers for vision loss and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event vision loss and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, vision loss was determined to be medically significant.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse reaction; vaccination dates: 05-AUG-2009; 10-OCT-2010; 14-SEP-2012; This spontaneous report has been received from a lawyer and a 63-year-old male patient via a Plaintiff Fact Sheet. On 05-AUG-2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown, reported as PPSV23) (strength, dose, route, lot #, expiration date not reported) for prophylaxis. Then the patient also received the pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown) vaccines on following dates: 10-OCT-2010 and 14-SEP-2012 (dose, route and lot were also unknown) (inappropriate schedule of product administration). There were no adverse reaction or side effects for the patient.   This is one of several reports split from a case in litigation (MARRS# 2010USA001766).; Sender's Comments:  US-009507513-2010USA001766: US-009507513-2101USA012803: US-009507513-2101USA012804:
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse reaction; vaccination dates: 25-OCT-2017; 06-MAR-2020; This spontaneous report has been received from a lawyer and a 72-year-old male patient via a Plaintiff Fact Sheet. On 25-OCT-2017, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacture unknown) (strength, dose, route, lot #, expiration date were unknown) for prophylaxis. Then the patient also received the hepatitis a vaccine, inactivated (manufacture unknown) vaccine on 06-MAR-2020 with unknown dose, route and lot# (inappropriate schedule of product administration). There were no adverse reactions or side effects for the patient.   This is one of several reports split from a case in litigation (MARRS# 2010USA001766).; Sender's Comments:  US-009507513-2010USA001766: US-009507513-2101USA012802: US-009507513-2101USA012804:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pyrexia, Skin swelling
Clinical narrative: fever; chills; red; swollen; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, erythema and swelling. On an unknown date, the outcome of the fever, chills, erythema and swelling were recovered/resolved.   The reporter considered the fever, chills, erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced fever, chills, so red and swollen for about a week. The patient had bad reaction to Shingrix. The reporter did not consent to follow up. This case has been linked with US2020AMR249311, reported by same reporter for same patient for Influenza vaccine Quadrivalent unspecified season vaccine. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249311:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Patient reported that after using shingles vaccine patient experienced headache.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but was captured as adult as per vaccine indication.  Patient reported that after receiving 1st dose of Shingrix in september 2020, patient experienced shingles. Patient wanted to know when 2nd dose could safely get.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Felt tired; Feeling achy; Feeling achy/ muscle pain; This case was reported by a consumer and described the occurrence of tiredness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and sickness. Previously administered products included Zostavax (Negative for zostavax).   On 14th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced tiredness, pain and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the tiredness and muscle pain were not recovered/not resolved and the outcome of the pain was unknown.   The reporter considered the tiredness, pain and muscle pain to be related to Shingrix.  Additional details were provided as follows. The age at vaccination was not reported. Patient previously received the Zostavax vaccine and found negative for that. Patient had Shingles and sickness in past. Patient received the 2nd dose of Shingrix on 14th December 2020 and felt tired and was feeling achy/ muscle pain. Patient received medication Tylenol and felt better than the day before reporting day. Patient was not completely recovered otherwise no fever, no GI symptoms and no headache. Patient stated that her husband and her three friends also had the Shingrix shots but did not experienced any symptoms and was comparing whether they was pre-treated with Tylenol or not. She also stated that it might be due to she had previous history of Shingles and her husband and her three friends was not having any history of a prior outbreak of shingles and they never had a shingles outbreak.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248570:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea
Clinical narrative: nausea; diarrhea; This case was reported by a consumer and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced nausea and diarrhea. On an unknown date, the outcome of the nausea and diarrhea were unknown.   It was unknown if the reporter considered the nausea and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Patient reported that after receiving the 1st dose of Shingrix in late August, patient experienced side effects such as nausea, diarrhea. Patient was asking about 2nd dose should be worse or same.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  Patient reported that after the 2nd dose of Shingrix experienced fever.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: felt a bit feverish; mild body aches; headache; This case was reported by a consumer and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 14th December 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 15th December 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the fever, general body pain and headache were unknown.   The reporter considered the fever, general body pain and headache to be possibly related to Shingrix. It was unknown if the reporter considered the fever, general body pain and headache to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the dose of Shingrix and Flu vaccine on monday, after that on tuesday patient experienced bit feverish with mild body aches and a headache. Patient was informed that these symptoms were good thing,showed that patient's body was beginning to build immunity to these viruses.
Sex: U
Vaccine: VARZOS
Symptoms: Ear congestion, Hypoacusis, Vertigo
Clinical narrative: my ears are blocked / Like talking in a cave; had some vertigo; This case was reported by a consumer and described the occurrence of vertigo in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced vertigo. On an unknown date, the patient experienced sensation of block in ear. On an unknown date, the outcome of the vertigo was recovering/resolving and the outcome of the sensation of block in ear was not recovered/not resolved.   It was unknown if the reporter considered the vertigo and sensation of block in ear to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had vertigo, which was better. The patient's ears were blocked which were still there at the time of reporting. The patient stated that, it was like talking in a case. The patient was asking as was that an issue of the injection or just weird timing.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: develop a rash; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but selected adult as per vaccine indication. The patient asked, if it was possible to develop rash after taking Shingrix shot. The patient did not consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: mild redness and soreness at injection site; soreness at injection site; This case was reported by a nurse and described the occurrence of injection site erythema in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient was an operating room nurse and she called to report the event. The patient received Shingrix and developed mild redness and soreness at injection site. The patient also received 2nd dose of Shingrix and experienced adverse events, for tolerance refer linked case US2020250693.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020250693:2nd dose, same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 10 days; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient refused to provide his date of birth (DOB). Two months before the date of reporting, the patient received Shingrix in left arm and experienced a sore arm for 10 days. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on the left side of the neck; This case was reported by a pharmacist and described the occurrence of neck rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2022) for prophylaxis.   On 11th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 14th January 2021, 3 days after receiving Shingrix, the patient experienced neck rash. On an unknown date, the outcome of the neck rash was not recovered/not resolved.   It was unknown if the reporter considered the neck rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 57 or 58 years. The patient received Shingrix in the left deltoid. The batch number of Shingrix was reported as ZLH9L, which was corrected to 2LH9L as per sales data sheet. The patient developed rash on the left side of the neck and was ongoing at the time of call. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Leg amputation, Neoplasm malignant
Clinical narrative: cancer; lost legs/Limb Amputation; Initial information was received on 28-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient) via media.  This case involves a male patient (age unspecified) who developed cancer (neoplasm malignant) and lost legs (leg amputation), while he received INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor  The past medical treatment, past vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious cancer (neoplasm malignant) and lost legs (leg amputation) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant, life-threatening and were leading to disability.  It is unknown if the patient experienced any additional symptoms/events  There were no lab data/results available  It was not reported if the patient received any corrective treatment.  The event outcome was unknown for both the events.  Information on the batch number was requested.  Follow-up information was received on 28-Nov-2020 regarding an unsolicited valid serious case from a consumer(patient) via  media.  Patient gender and seriousness was added Suspect was updated to Influenza vaccine.; Sender's Comments: Follow-up information received on 28-Nov-2020, changes previous assessment: This poorly documented case involves a male patient who had neoplasm malignant and leg amputation after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information received on 16-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves an adult patient of an unknown gender who experienced sore arm (pain in extremity), while the patient received vaccine INFLUENZA VACCINE.  The patient did not have medical history, concomitant disease, or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was reported.  On an unknown date, the patient received dose of suspect INFLUENZA VACCINE (strength and formulation unknown) (lot number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) after the administration of suspect therapy, the patient experienced sore arm (pain in extremity).  No laboratory data was reported.  It was unknown if the patient received a corrective treatment.  At the time of report, the outcome of the event was unknown.  There would be no information regarding batch number for the case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 16-Jan-2021 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient an unknown age and gender who experienced flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) 3 to 4 weeks following the administration of INFLUENZA VACCINE.  Patient reported that's why I don't get a flu vaccine. Each time I was getting one, 3-4 weeks later I was getting a flu and not in a weak form.  It is unknown if the patient experienced any additional symptoms/ events.   Medication Details and reason for taking the medicine: Indication: Not provided.   It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Intensive care, Malaise
Clinical narrative: haven't been sick since patient stopped getting the shot and spent two years in a row in icu; Initial information was received on 20-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-hcp (healthcare professional).  This case involves a patient with unknown demography who got sick and spent two years in a row in ICU (Intensive Care Unit) (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got (spent two years in a row in ICU (Intensive Care Unit)) (illness), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  The reporter reported that he/she get the flu shot every year but now he/she was not taking a shot for corona. He/she asked did anyone ever asked if there would be any long term effects after the shot for Corona and what does the shot contain.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case involves a patient with unknown demography who experienced illness, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Patient got the flu but was probably a new strain; Initial information was received on 23-Jan-2021 regarding an unsolicited valid non-serious case from social media via consumer or non-health care professional (Patient)   This case involves patient [age and gender unspecified] who got the flu but was probably a new strain (influenza), while patient received INFLUENZA VACCINE [Flu shot].   It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient got the flu but was probably a new strain (influenza) (non-serious) 2 month following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  Details of laboratory data not reported (It is unknown if there were lab data/results available).  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Patient gotten sick every year from the flu shot; Initial information was received on 23-Jan-2021 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who gotten sick every year from the flu shot (illness), while patient received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient gotten sick every year from the flu shot (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient have not taken it in years and haven't been sick like that since.  Details of laboratory data not reported (It is unknown if there were lab data/results available).  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given the product twice in a 1 month timeframe with no reported adverse event; Initial information was received on 15-Jan-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves patient (of an unknown age and gender) who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] twice in a 1 month timeframe with no reported adverse event, [lot number and expiry date not reported) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination (extra dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error due to extra dose administered. (latency: at the time of vaccination).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Vaccine on January 22. Rash close to injection site began on Friday, January 29. Area got larger on Saturday and Sunday January 30 and 31. I think it is called covid arm. Put Benadryl cream on it.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Had a low grade fever (99.6) for approximately 48 hours and cleared Sunday 1/31/2021. Accompanied with body aches
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA . Injected incorrectly 1cm below acromin process.  2hrs post injection severe pain (even now), immobility of joint, severe ROM limitation. Unable to perform ADLs.  Severe pain
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Immediately after receiving the 2nd dose of the Pfizer vaccine, I had muscle pain at the injection site and difficulty lifting that arm the next day (similar reaction as after the 1st dose). I received the vaccine Wednesday evening (6 p.m.) on 1/13/21. Around 2 p.m. the next day, I started having a fever (over 101 degrees); chills; body aches; and fatigue. These symptoms lasted for three days but the fever was slowly going down with Advil. By Saturday evening, my symptoms changed to headaches and diarrhea, which lasted for an additional three days after that. My nose suddenly started running the following afternoon (Wednesday, 1/20/21) for about an hour and then that stopped and did not recur. All symptoms were gone by Thursday, 1/21/21 and I had none of these symptoms prior to taking the second dose of the vaccine (other than the arm pain for 1-2 days following the 1st dose of the vaccine).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Immediately after receiving the 2nd dose of the Pfizer vaccine, I had muscle pain at the injection site and difficulty lifting that arm the next day (similar reaction as after the 1st dose). I received the vaccine Wednesday evening (6 p.m.) on 1/13/21. Around 2 p.m. the next day, I started having a fever (over 101 degrees); chills; body aches; and fatigue. These symptoms lasted for three days but the fever was slowly going down with Advil. By Saturday evening, my symptoms changed to headaches and diarrhea, which lasted for an additional three days after that. My nose suddenly started running the following afternoon (Wednesday, 1/20/21) for about an hour and then that stopped and did not recur. All symptoms were gone by Thursday, 1/21/21 and I had none of these symptoms prior to taking the second dose of the vaccine (other than the arm pain for 1-2 days following the 1st dose of the vaccine).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Electrocardiogram abnormal, Hypotension, Immediate post-injection reaction
Clinical narrative: Got shot at church at 11:00 AM, had adverse effects immediately after sitting down. Started off being disoriented and light headed which led to me losing consciousness. Would go in and out of consciousness until sternum checked multiple times. Got picked up by the ambulance and taken to the hospital as blood pressure was low and was fevering per first responder. Had an ekg with tachycardia, once delivered to the hospital. Still in and out of consciousness. Stayed there roughly 6-7 hours and received fluids and magnesium before being discharged,
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pyrexia, Tachycardia
Clinical narrative: Got shot at church at 11:00 AM, had adverse effects immediately after sitting down. Started off being disoriented and light headed which led to me losing consciousness. Would go in and out of consciousness until sternum checked multiple times. Got picked up by the ambulance and taken to the hospital as blood pressure was low and was fevering per first responder. Had an ekg with tachycardia, once delivered to the hospital. Still in and out of consciousness. Stayed there roughly 6-7 hours and received fluids and magnesium before being discharged,
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Nausea, Pain
Clinical narrative: Fever of 100.1; chills, body aches, lasting for 24 hours Fatigue, injection site soreness, Nausea without vomiting lasting for (at time of writing) 48 hours
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 100.1; chills, body aches, lasting for 24 hours Fatigue, injection site soreness, Nausea without vomiting lasting for (at time of writing) 48 hours
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever 101.7 Chills started around 5:00 PM or about 32 hours after injection.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Feeling cold
Clinical narrative: One hour after vaccine, arm began to hurt then progressed to hurting so much I could not lift it for two days without significant pain. By 7 hours after vaccine, chills and fatigue started and I could not get warm. That same night upset stomach and migraine as well as hot sweats between the chills. No fevers noted. These symptoms worsened on the next day. Very fatigued all day and little to no appetite. Sunday started improving but easily fatigued with walking more than 100 feet. Still little appetite. Able to eat half usual amount at dinner that night. No chills anymore. Still sweats. Monday still easily fatigued but not as bad as sunday. Appetite improving. Still sweats with minimal exertion.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Migraine, Mobility decreased, Pain in extremity
Clinical narrative: One hour after vaccine, arm began to hurt then progressed to hurting so much I could not lift it for two days without significant pain. By 7 hours after vaccine, chills and fatigue started and I could not get warm. That same night upset stomach and migraine as well as hot sweats between the chills. No fevers noted. These symptoms worsened on the next day. Very fatigued all day and little to no appetite. Sunday started improving but easily fatigued with walking more than 100 feet. Still little appetite. Able to eat half usual amount at dinner that night. No chills anymore. Still sweats. Monday still easily fatigued but not as bad as sunday. Appetite improving. Still sweats with minimal exertion.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On  01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site paraesthesia, Myalgia, Vision blurred
Clinical narrative: The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On  01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Cough, Diarrhoea, Pain in extremity
Clinical narrative: Cough (mild - no trouble breathing) & Diarrhea 1.30 / chills 1.31 / leg & back pains 1.31-2.1 / continuing cough
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Shortly after receiving the vaccine, my arm was sore. All the typical side effects in the paperwork I had. The next day I had a low fever of 99.9 and I noticed my arm was red. It is still red as of today it is about 3 inches in width. I went back to the pharmacist to let them look at it and they referred me to contact VAERS. It is not bothering or anything like that.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Headache, Hypogeusia
Clinical narrative: Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sense of smell and taste lower down, tonsil swelling,  Lymph node swelling and pain.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hyposmia, Lymph node pain, Lymphadenopathy, Myalgia, Neuralgia
Clinical narrative: Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sense of smell and taste lower down, tonsil swelling,  Lymph node swelling and pain.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tonsillar hypertrophy
Clinical narrative: Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sense of smell and taste lower down, tonsil swelling,  Lymph node swelling and pain.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: Swelling of arm and injection site. With itchy ness , chills , major fatigue. After 1 week after injection
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Migraine, Muscle spasms
Clinical narrative: Beginning the night of the 27th, I had a headache and a low-grade fever. I woke up in the middle of the night with a 102.7 fever, severe migraine, severe body aches, leg cramps, sore throat/swelling, and chills. I alternated taking ibuprofen and tylenol to try to control the pain, to no avail. I used bengay and cool washcloths for pain and to cool off. These did not help either. I made sure to keep drinking water and pedialyte. I took benadryl to try to sleep and help with my throat swelling up, it did not help.  All of this was non-stop until the morning of the 30th. That morning when I woke up my fever was going down and I no longer had the chills. I still had the severe headache, body pains, cramping, swollen/sore throat, and now diarrhea. Today is 2/1 and I am still experiencing severe body aches, severe headache, leg cramps, "nerve pain" type feeling in my arms, GI issues, and a sore/swollen throat.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pharyngeal swelling, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Beginning the night of the 27th, I had a headache and a low-grade fever. I woke up in the middle of the night with a 102.7 fever, severe migraine, severe body aches, leg cramps, sore throat/swelling, and chills. I alternated taking ibuprofen and tylenol to try to control the pain, to no avail. I used bengay and cool washcloths for pain and to cool off. These did not help either. I made sure to keep drinking water and pedialyte. I took benadryl to try to sleep and help with my throat swelling up, it did not help.  All of this was non-stop until the morning of the 30th. That morning when I woke up my fever was going down and I no longer had the chills. I still had the severe headache, body pains, cramping, swollen/sore throat, and now diarrhea. Today is 2/1 and I am still experiencing severe body aches, severe headache, leg cramps, "nerve pain" type feeling in my arms, GI issues, and a sore/swollen throat.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hyperhidrosis, Nausea
Clinical narrative: severe headache, nausea, cold sweats
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Feeling cold, Hyperhidrosis
Clinical narrative: 3:45 pm Patient c/o feeling dizzy at 3:45 pm. Daughter and son in law present and requested water. Patient took a few sips of water and soon after became cool and clammy. Patient became incoherent and was not responding to myself or her daughter. Became lethargic and couldn't hold her head up. Diaphoretic and skin remained cool and clammy. Client is not diabetic. Patient is on meds for B/P and did have cardiac bypass surgery 2 years ago. Daughter and I decided to call an ambulance. B/P 80/40 (L) and rechecked 5 min later and was 90/50. No SOB or trouble breathing. Lung sounds were clear and WNL. No respiratory distress noted. O2 sat 94%. Pulse 55. Ambulance arrived and took over care. Patient did get transferred to ER  via ambulance per the daughter's request