chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu twice; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involved Adult patient who had the flu twice (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) patient developed a non-serious flu twice (influenza) after the administration of INFLUENZA VACCINE.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: patient got one last year It nearly killed patient seriosly not exaggerating; Initial information was received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got one last year it nearly killed patient seriously not exaggerating (feeling abnormal), while patient was treated with influenza vaccine.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got one last year it nearly killed patient seriously not exaggerating (feeling abnormal).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Every time I have taken one I have gotten sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 14-Dec-2020.  This case involves an unknown age patient who reported every time had taken one patient gotten sick (Illness), while he/she received vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported every time had taken one patient gotten sick (Illness), following the administration of INFLUENZA VACCINE. Patient reported So if it was not the flu what was it, patient will never take another since they were only 35% effective in patient age group. Also had the flu in 10 years without the flu shot.  Relevant laboratory test was not reported.  Final diagnosis was Illness.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.   There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I have never had the flu except when I got the flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and was transmitted to sanofi on 14-Dec-2020.  This case involved a patient of unknown age and gender who never had the flu except when patient got the flu shot (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported for prophylactic vaccination.  On an unknown date, latency unknown, it was reported patient never had the flu except when patient got the flu shot (influenza).  No laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got a flu shot one time it have me the flu; Initial information regarding an unsolicited valid non-serious case received on 15-Dec-2020 from a consumer (patient) via social media.  This case involved a patient of unknown demographics who got a flu shot one time it had patient the flu (Influenza), while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient got a flu shot one time it had patient the flu (Influenza), following the administration of INFLUENZA VACCINE.  Patient hadn't had a shot since and haven't had the flu Either.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was reported as Unknown for reported event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: local reaction at injection sight. Some redness, swelling, soreness; local reaction at injection sight. Some redness, swelling, soreness; local reaction at injection sight. Some redness, swelling, soreness; local reaction at injection sight. Some redness, swelling, soreness; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 15-Dec-2020.  This case involved a patient who experienced local reaction at injection sight, some redness, swelling, soreness (vaccination site reaction), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, past vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced local reaction at injection sight, some redness, swelling, soreness (vaccination site reaction, vaccination site erythema, vaccination site swelling and vaccination site pain), unknown latency following the administration of INFLUENZA VACCINE.  It was reported that it usually resolves in day or two. No big deal.  Relevant laboratory test was not reported.  Final diagnosis was vaccination site reaction with symptoms such as vaccination site erythema, vaccination site swelling and vaccination site pain.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient was recovering from the reported events.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got so sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 15-Dec-2020.  This case involved a patient of unknown demographics who got so sick (Illness), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got so sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  The patient was in bed for 3 days and could not make a sound.  Relevant laboratory test was not reported.  Final diagnosis was got so sick.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: very sick every time; Initial information was received on 15-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a 82 year old patient (gender unspecified) who was very sick every time (Illness), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (many year ago), 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 was very sick every time (Illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   The patient quit getting it many years ago and have not had the flu since.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: end up in the hospital everytime with the flu; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved unknown age patient for whom end up in the hospital everytime with the flu (Flu) was reported, while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, for the patient end up in the hospital everytime with the flu (Flu) was reported, unknown latency following the administration of INFLUENZA VACCINE.   Final diagnosis was end up in the hospital everytime with the flu.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for end up in the hospital everytime with the flu.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: it makes me very sick, got shots only 2 times; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 15-Dec-2020.  This case involved a 75-year-old patient who reported it makes me very sick (Illness), got shots only 2 times, after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported a non-serious, got shots only 2 times and made the patient very sick (Illness) , unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was  illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 15-Dec-2020.  This case involves a patient of unknown demographics who always got the flu (influenza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that he/she always got the flu (influenza) 7to 10 days after the patient got the shot.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case received was received from a consumer via social media.  This case involves an unknown age patient for who developed flu (influenza), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, (Unknown latency) following the administration of Influenza Vaccine, developed flu (influenza).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 15-Dec-2020.  This case involves a patient of unknown demographics who got flu (Influenza ), while the patient received Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date (unknown latency), the patient got flu (Influenza) every time when received influenza vaccine.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: second shingles shot is a hum dinger arm sore; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 14-Dec-2020.  This case involves a patient of unknown demographics who experienced second shingles shot is a hum dinger arm sore (Vaccination site pain), while the patient received vaccine Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s), 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 not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient got both of them the same day and reported that second shingles shot was a hum dinger arm sore for three days.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Sinus disorder
Clinical narrative: violently sick; continues sinus isuues for life; Initial information regarding an unsolicited valid non-serious social media case was received from a consumer (patient) on 15-Dec-2020.  This case involved patient with unknown demographics, who got sick (Illness) and continues sinus issues for life (sinus disorder), while he/she received vaccine Influenza Vaccine.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient reported that always got sick (Illness) and continues sinus issues for life (sinus disorder), following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got a flu shot and got really sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and was transmitted to Sanofi on 15-Dec-2020.  This case involved a patient of unknown age and gender who got a flu shot and got really sick (Illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported for prophylactic vaccination.  On an unknown date, latency unknown, patient got a flu shot and got really sick (illness).  No laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown.  There will be no information available on the batch number.
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Haematemesis, Vomiting
Clinical narrative: weak for a couple of days; start throwing up within 4 to 6 hours and can't quit until everything is up including blood; Initial information regarding this unsolicited valid non-serious social media case reported by consumer (patient) and transmitted to Sanofi on 16-Dec-2020.  This case involves an unknown age patient who was weak for a couple of days (Asthenia) and start throwing up within 4 to 6 hours and cannot quit until everything is up including blood (vomiting), while he/she received vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who was weak for a couple of days (Asthenia) and start throwing up within 4 to 6 hours and cannot quit until everything is up including blood (vomiting) was reported.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There would be no information available on batch number for this case.
Age: 20.0
Sex: U
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: the patient took the required shots for little ones and he collapsed on the table; Initial information regarding an unsolicited valid serious social media case received was from a consumer and transmitted to Sanofi on 16-Dec-2020.  This case was linked to case 2020SA361491 (15 year old patient).  This case involved a 20 year old patient of unknown demographics who took the required shots of INFLUENZA VACCINE for little ones and collapsed on the table (syncope).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported), for little ones, via unknown route in unknown administration site for prophylactic vaccination and collapsed on the table (syncope), unknown latency following the administration of INFLUENZA VACCINE.  The event was assessed as medically significant as per important medical event (IME) list.  Relevant laboratory test was not reported.  Final diagnosis was syncope.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.; Sender's Comments: Sanofi company comment dated 20-Dec-2020: This case concerns a  20 year old patient who collapsed after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: made patient sick; Initial information regarding an unsolicited valid non-serious case from a consumer via social media on 15-Dec-2020.  This case involved a 33 year old patient who made patient sick (Illness), while patient received vaccine INFLUENZA VACCINE.  The patient's past medical treatment included INFLUENZA VACCINE.  Concomitant medication was unknown.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site.    On an unknown date (latency unknown), after administration of INFLUENZA VACCINE, the patient made sick (illness).  Final diagnosis was illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, event outcome was unknown.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got a flu shot twice and was sick both times for 3 weeks; Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).   This case involves a patient of an unknown demography who was sick (illness) for 3 weeks, after receiving INFLUENZA VACCINE both the times.   The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received two doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site.  On an unknown date, the patient was sick (illness) for 3 weeks, unknown latency following the administration of INFLUENZA VACCINE both the times.  No laboratories details reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information about batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: get really sick; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (Patient) via social media.   Medical history, medical treatment(s), past vaccination, family history and concomitant medication was not reported.   On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site.    On an unknown date (unknown latency), the patient got INFLUENZA VACCINE and patient got get really sick  (illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Lip swelling, Pruritus
Clinical narrative: blotchy red, itchy face, puffy swollen lips, redness and swelling to right deltoid area of immunization
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Skin swelling
Clinical narrative: blotchy red, itchy face, puffy swollen lips, redness and swelling to right deltoid area of immunization
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Patient got flu 16 years ago; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved an unknown age patient who got flu 16 years ago (Influenza), after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date (reportedly 16 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.   On an unknown date, it was reported that patient got flu 16 years ago (Influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory test included COVID-19 test.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: same thing happens to me; Initial information was received on 15-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.   This case involves a patient (age and gender unspecified) who was sickness (Illness), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient was sickness (Illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypoaesthesia, Paraesthesia, Presyncope
Clinical narrative: On 12/20 at 9am started having left sided facial numbness, tingling, flushing. Near syncope episode (tachycardia, diaphoretic, blurred vision) around 1130am. Took Benadryl seemed to help. On 12/21- around 7a near syncope episode, tachycardia, diaphoretic, facial flushing, itching.  Took Benadryl-improvement in facial itching, decreased heart rate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tachycardia, Vision blurred
Clinical narrative: On 12/20 at 9am started having left sided facial numbness, tingling, flushing. Near syncope episode (tachycardia, diaphoretic, blurred vision) around 1130am. Took Benadryl seemed to help. On 12/21- around 7a near syncope episode, tachycardia, diaphoretic, facial flushing, itching.  Took Benadryl-improvement in facial itching, decreased heart rate.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I get sick every time; Initial information regarding this unsolicited valid non-serious social media case received from a consumer on 16-Dec-2020.  This case involved a patient who get sick every time, after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.   On an unknown date, the patient get sick every time (Illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was get sick every time.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip erythema, Pruritus, Skin exfoliation
Clinical narrative: REDNESS ON THE UPPER LIP, SCALE AND ITCHING IN THE AREA.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Musculoskeletal chest pain, Pyrexia, Rash
Clinical narrative: Rash on chest pounding headache fever of 104 left side rib pain elevated heart rate 106
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the flu shot I have the flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 16-Dec-2020.  This case involved a unknown patient who got the flu shot reported, I have the flu (Influenza), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.   On an unknown date, the patient reported (non-serious), got the flu shot and have the flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was influenza.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site swelling, Nausea, Tremor
Clinical narrative: The shot site was swollen for two days after the injection.  I had nausea, dizziness, and tiredness.  Three days after the injection (today), I had shakiness, extreme fatigue  and felt like I was going to pass out.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: nurse mistakenly gave a 7 month old and 3 1/2 year old FLUBLOK with no adverse event; nurse mistakenly gave a 7 month old and 3 1/2 year old FLUBLOK with no adverse event; Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious case (reference number: US-SANOFI-00396192) via other health professional.  This case is linked to case 2020SA362391.  This case involves a 3-year-old patient for whom it was reported that nurse mistakenly gave a 3 1/2 year old flublok (Product administered to patient of inappropriate age ),  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site.   On an unknown date, it was reported that nurse mistakenly gave a 3 1/2 year old flublok (Product administered to patient of inappropriate age and Overdose), (unknown latency) INFLUENZA QUADRIVALENT RECOMBINANT VACCINE .  It is also an actual medication error case due to inappropriate age at vaccine administration.  Relevant laboratory test was not reported.  The outcome was not applicable for both the events.  There would be no information available on batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: started to develop injection site soreness on the night of vaccine then by 10am the next day was having all over body aches, nausea, headache which continued to get worse and by 3pm that day had nausea, vomiting , severe body aches and cramping all over, fever, headache, and a hard warm lump at the injection site. was applying heat  to cramps and taking Tylenol which was not helping much for body aches, did not want to take ibuprofen due to nausea. by noon on the 3rd day most of it was resolved
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: started to develop injection site soreness on the night of vaccine then by 10am the next day was having all over body aches, nausea, headache which continued to get worse and by 3pm that day had nausea, vomiting , severe body aches and cramping all over, fever, headache, and a hard warm lump at the injection site. was applying heat  to cramps and taking Tylenol which was not helping much for body aches, did not want to take ibuprofen due to nausea. by noon on the 3rd day most of it was resolved
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient described feeling numbness under the right eye.  The numbness radiated down the right side of the face.  Patient reported that the numbness subsided after 2 minutes
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: the patient came down with the flu every year; Initial information regarding this unsolicited valid non-serious case received from a consumer on 16-Dec-2020.   This case involved a male patient who came down with the flu every year, while he received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Parkinson's disease.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.    On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right arm with 2.5-3" long 1.5-2" wide reddened, warm to touch, developed the day after vaccine. Seen by OHS rec. Ice, Benadryl, Antihistamine.  Today she returned with decreased swelling & redness.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Muscular weakness, Pain, Pain in extremity
Clinical narrative: an ongoing feeling to the left arm described as having a sore, heavy feeling, and weak left arm that has never stopped since getting the injection; an ongoing feeling to the left arm described as having a sore, heavy feeling, and weak left arm that has never stopped since getting the injection; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) on 16-Nov-2020.  This case involves a 54-year-old female patient who had an ongoing feeling to the left arm described as having a sore, heavy feeling, and weak left arm that has never stopped since getting the injection (muscular weakness and limb discomfort), while she received INFLUENZA VACCINE.  The patient's past medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.    On 09-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown strength standard) at a dose of 0.5 mL via an intramuscular route in the left arm prophylactic vaccination.   On 09-Oct-2019, patient had an ongoing feeling to the left arm which she described as having a sore, heavy feeling, and also had weak left arm that has never stopped since getting the injection (muscular weakness and limb discomfort). The consumer reported that she was not sure of the exact name of the vaccine but the administrating pharmacy reported it was by Sanofi and supplied the Sanofi phone number.   Patient had felt normal to the first moments after her injection and later that after three months she continued to having the feeling in her arm. She went to the pharmacy and reported that when she places her arm under the pillow or if she put any weight on the arm it was sore and weak. She had not seen a provider due to cost and was not thinking anything could be done about the feeling and at times her left arm was fine for a while but with doing anything like picking up her small dog had caused her a flare of the soreness. For the treatment she was moving the arm and working out the soreness. Patient and her daughter got the flu vaccine on the same day but her daughter did not have any issues.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as not resolved for both the events.  There will be no information regarding the batch number for the case.
Age: 59.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: DAPTACEL injection that was administered instead of Adacel with no AE; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 59 years old male patient who received 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5611BA, expiry date: 03-APR-2021) instead of Adacel via intramuscular route in the left deltoid on 18-Nov-2020 for prophylactic vaccination (wrong product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the Wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Paraesthesia
Clinical narrative: Started 15 minutes after vaccination and it lasted for 30 minutes. Tingling arms and fingers and heaviness in shoulder. Resolved.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Joint swelling, Pruritus
Clinical narrative: Employee reported redness and swelling to Right Wrist. She also noted itching to left neck/back area. Employee was taken to ED for further evaluation and treatment.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Swollen tongue, Tongue pruritus
Clinical narrative: Approximately 30 minutes after COVID vaccine administered, patient reported tongue swelling/itching sensation to tongue and roof of mouth.  This lasted about 15 minutes and resolved on its own without treatment.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Patient experienced nausea and fatigue a couple of days after getting the vaccine
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient was given a extra dose of MENACTRA in error; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Agency (Reference number- 00365781) and transmitted to Sanofi on 19-Nov-2020.  This case involves a 16 year old female patient was given a extra dose of MENACTRA in error (extra dose administered), while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included first booster dose of MENACTRA in unknown date in 2016. Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was a potential medication error due to extra dose administered.  On 02-Nov-2020, the patient received a second booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 mL (lot number U6827BB, Expiration Date: 18-FEB-2022, Strength Standard) via an intramuscular route in the left arm and On 19-Nov-2020, she also received a third booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE in error (extra dose administered).  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Joint stiffness, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Significant Cervical/thoracic joint pain and stiffness which referred to R shoulder girdle region, limited cervical ROM to the R.  Dull, achey pain in area even without movement. Took acetaminophen and tumeric for anti inflammatory, use of heating pad and then biofreeze cream for analgesic purposes.  By next morning pain and stiffness centralized back to spinal region and R shoulder girdle was pain free with normal ROM. Same treatments used again.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Significant Cervical/thoracic joint pain and stiffness which referred to R shoulder girdle region, limited cervical ROM to the R.  Dull, achey pain in area even without movement. Took acetaminophen and tumeric for anti inflammatory, use of heating pad and then biofreeze cream for analgesic purposes.  By next morning pain and stiffness centralized back to spinal region and R shoulder girdle was pain free with normal ROM. Same treatments used again.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Face oedema
Clinical narrative: Mild Edema Left Side of Face
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: patient was administered with IPOL that expired/no AE; Initial information regarding this unsolicited valid non-serious case via Medical Information (Reference number- 00366463) was received from a Other Healthcare Professional and transmitted to Sanofi on 20-Nov-2020.  This case involved a 13 month old female patient who was administered with ipol that expired (Expired product administered), while she received IPV (VERO) [IPOL].  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunisation.  On 19-Nov-2020, the patient received a 0.5ml dose of suspect IPV (VERO) lot number- PIE701M and expiration date- 09-Nov-2020 via intramuscular route at left arm site for prophylactic vaccination.  It was a potential medication error due to incorrect product storage (Expired vaccine used).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood culture negative, Chills, Computerised tomogram normal, Echocardiogram normal, Magnetic resonance imaging normal
Clinical narrative: Patient had chill starting 2 days after surgery. Chills lasted for about 1 week. Developed a low grade fever of 100.6.  Then patient demonstrated neurological issues-patient could not remember is doctor's name or his wife's name. Could not recall the words for typical household items.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Memory impairment, Neurological symptom, Pyrexia, SARS-CoV-2 test negative, Scan with contrast normal
Clinical narrative: Patient had chill starting 2 days after surgery. Chills lasted for about 1 week. Developed a low grade fever of 100.6.  Then patient demonstrated neurological issues-patient could not remember is doctor's name or his wife's name. Could not recall the words for typical household items.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: injection site pain, slight fever, tiredness, headache
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Dysphagia, Dyspnoea, Urticaria
Clinical narrative: Patient received Pfizer vaccine dose 1 IM in L deltoid per portcol. During 15 min post vaccine monitoring, patient developed a cough, SOB, diff swallowing and hive like rash within 10 minutes of vaccine administration